Herbal remedies linked to drug side effects
Taking herbal remedies and dietary supplements alongside drugs like aspirin could cause harmful side effects, experts claim.
By Katherine Harmon | Scientific American – Fri, Sep 21, 2012
When hormone replacement therapy
was found to put some menopausal women at increased risk of cancer and
cardiovascular disease, many went in search of safer treatments to
decrease their symptoms. In the ensuing decade Black cohosh has won out as an overwhelming consumer favorite, now reaping millions of dollars in sales each year.
But controlled trials of this supplement
have seen mixed results, sometimes showing it to be effective in
relieving hot flashes, sleep disruptions, mood swings and other symptoms
whereas other times revealing it to be ineffective. And some case
reports even suggest that it can be toxic, damaging the liver.
This messy track record gave Damon Little,
a bioinformaticist at The New York Botanical Garden (NYBG), and his
colleagues an idea: What if patients—in these trials and out in the
community—were not always taking pure, actual Black cohosh (Actaea racemosa), but one or more related species? Fortunately, they had just the tool on hand to figure that out: DNA barcoding.
Using this technology, which locates and sequences specific areas of a plant's genome (specifically, two matK
gene nucleotides), they were able to determine that one quarter of
commercially available "Black cohosh" pills were not the herb at all. Their findings were published this July in the Journal of AOAC International.
"Misidentification and adulteration in Black cohosh supplements [has
been] known for many years as a matter of concern," notes Rolf Teschke,
an internist at the Teaching Hospital of the Johann Wolfgang Goethe
University in Frankfurt and who was not involved in the new research.
"The present study confirms—but extends—previous findings."
Unlike drugs, however, supplements are not required to be tested for safety or efficacy
by the U.S. Food and Drug Administration before they hit the market.
And testing to make sure the contents match the label are much more lax
than it is for pharmaceuticals, opening the opportunity for mislabeling,
whether it is accidental or intentional.
Wild roots
Black cohosh has been used traditionally by Native Americans as a natural remedy for a variety of ailments. It is often harvested in the wild, where it grows in similar environments to many of its close cousins that look very similar. And some species of Actaea are suspected to be toxic to humans. "Unless you're looking very carefully, you can't assume that any Black cohosh like thing is actually Black cohosh," Little says. In eastern North America, where Black cohosh grows, it is not uncommon to also find yellow cohosh (A. pachypoda and A. podocarpa) and baneberry (A. spicata and A. rubra). During harvesting, the rhizomes (buried stems) are often collected and then ground up to make the supplements, leaving telling botanical clues, such as leaf shape, forever lost.
Black cohosh has been used traditionally by Native Americans as a natural remedy for a variety of ailments. It is often harvested in the wild, where it grows in similar environments to many of its close cousins that look very similar. And some species of Actaea are suspected to be toxic to humans. "Unless you're looking very carefully, you can't assume that any Black cohosh like thing is actually Black cohosh," Little says. In eastern North America, where Black cohosh grows, it is not uncommon to also find yellow cohosh (A. pachypoda and A. podocarpa) and baneberry (A. spicata and A. rubra). During harvesting, the rhizomes (buried stems) are often collected and then ground up to make the supplements, leaving telling botanical clues, such as leaf shape, forever lost.
In recent years, with the vast increase in the herb's sales, commercial growing operations have also sprung up in North America as well as Europe and Asia.
David Baker, a gynecologist at Stony Brook University Medical Center,
had many patients who took Black cohosh, but he was intrigued by the
ambiguity of the medical literature on the supplement. So he, Little and
their colleague at the NYBG, Dennis Stevenson, wanted to see if all of
these pills labeled as Black cohosh were, indeed the correct species.
Sampling supplementsTo test just how reliable the supplement's label was, the researchers sequenced plant material from 36 supplements purchased in the New York City area and online.
One quarter of those contained another species entirely—not just in addition to Black cohosh, but instead of Black cohosh . "The samples, as far as we found, were purely the wrong
sample," Little says. The version of the sequencing they ran would not
have picked up low levels of contamination (below about 10 percent), but
Little notes that they could ramp it up and look more closely if they
suspected some samples held minuscule portions of other herbs.
None of the mislabeled supplements were from other North American species of the Actaea genus. Instead, they were Asian species: A. cimicifuga, A. dahurica and A. simplex.
That means "they're not growing in the wild next to real Black cohosh"
in North America, Little says. So it is unlikely these adulterated
supplements were the result of mistakes made by wild harvesters. Rather,
these plants' presence in the supplements were from mislabeling of
seeds or the rhizomes themselves that were then sold to supplement
manufacturers.
Some other species of Actaea are sometimes marketed for relief
of similar symptoms that Black cohosh helps to diminish. But these
species do not have the same cachet, and thus are not likely to bring in
as much money. "So there's a huge financial incentive for them to be
mislabeled," Little says. And their safety has yet to be tested.
Link for uncertainty?
Not everyone is convinced that Black cohosh supplements explain the mixed results from trials of the herb. Teschke and his colleagues have authored numerous papers that took aim at the link between Black cohosh and reports of toxicity. Dozens of case reports and reviews of clinical trials fail to make a convincing case for Black cohosh specifically being to blame. Teschke notes that this might be due to the fact that Black cohosh as it is used in clinical trials is more carefully regulated (often as a drug, rather than as a supplement), especially in Europe, where many of the studies have been done. "In the U.S. regulatory surveillance is not stringent enough for Black cohosh and other herbal supplements," he notes, suggesting that this market might be more vulnerable to adulterated supplements.
Not everyone is convinced that Black cohosh supplements explain the mixed results from trials of the herb. Teschke and his colleagues have authored numerous papers that took aim at the link between Black cohosh and reports of toxicity. Dozens of case reports and reviews of clinical trials fail to make a convincing case for Black cohosh specifically being to blame. Teschke notes that this might be due to the fact that Black cohosh as it is used in clinical trials is more carefully regulated (often as a drug, rather than as a supplement), especially in Europe, where many of the studies have been done. "In the U.S. regulatory surveillance is not stringent enough for Black cohosh and other herbal supplements," he notes, suggesting that this market might be more vulnerable to adulterated supplements.
Nevertheless, Little thinks that this contamination "is probably a
pretty strong explanation" for the herb's erratic track record, he says.
But we lack crucial evidence to prove that, including samples of what
was used in clinical trials. Currently, those executing these sorts of
clinical trails are not required to archive samples of the products they
used, so there is no way to perform DNA bar coding of the actual
supplements study subjects were receiving.
And for consumers, there is still no way to know with certainty that
pills labeled as Black cohosh actually are—without access to the
bar-coding technology the researchers used. Little and his colleagues
found mislabeling even among the most expensive brands they sampled. But
they declined to release the names of the companies (for fear of legal
action) and because content could vary from batch to batch, as they are
often sourced from different suppliers.
He and others who have been following the challenge of monitoring
herbal supplements in the U.S. have recommended more frequent and more
thorough testing of contents by manufacturers. But instituting this is
always a question of paying for the equipment or lab time and allocating
more FDA resources to monitoring.
Tracking supplements based on genetic material, however, could become
commonplace. Any preparation using plant parts that are ground up or
compressed to be put into a tablet or capsule offer promising fodder for
DNA testing. Even some extracts, whether oil or alcohol-based, can
often yield some bits of the original plant that can be used for genetic
sequencing. Little and his co-authors originally purchased 40 randomly
selected brands of dried Black cohosh supplements, but four did not
offer any genetic material for testing. This is likely because they had
been heated during processing to an extent that destroyed the DNA—a key
challenge for this testing method.
The NYBG researchers are already setting their sights on other popular
plant-based supplements. Supplements currently under study include saw
palmetto (from Serenoa repens, often used for prostate troubles); ginseng (in the Panax genus, marketed for improved mental function); devil's claw (Harpagophytum procumbens, sometimes indicated for arthritis or other ailments); and even garlic (Allium sativum, often taken for cardiovascular health, which they suspect might sometimes be adulterated with elephant garlic—A. ampeloprasum—a similar species, but one that has not been subject to the same testing as common garlic itself).
Many of these other supplements are not likely to carry the possibility of toxicity the same way that Black cohosh does. But, as Little maintains, "you should know what you're buying."
Follow Scientific American on Twitter @SciAm and @SciamBlogs.
Visit ScientificAmerican.com for the latest in science, health and technology news.
© 2012 ScientificAmerican.com. All rights reserved.
© 2012 ScientificAmerican.com. All rights reserved.
Children's herbal cough and cold withdrawn as potentially dangerous
A children's herbal medicine has been withdrawn after regulators found it was unlicensed and potentially dangerous.
======================
Questions Raised About The Safety Of Natural Treatments For Menopause
With the risks associated with hormone replacement therapy (HRT), many women have turned to natural menopause solutions. But these also can bring risks. New report documents risks and introduces a safe and reliable alternative for women going through menopause
After
the literature revealed some of the adverse events associated with Black cohosh and genistein, I began to discourage my patients from using
them.
Santa Fe, NM (PRWEB) August 08, 2012
Today branded ingredient distributor Helios CORP/Sunbio released a special report on the risks women may face taking popular natural treatments for menopause.
The report discusses data from studies on Black cohosh, genistein and
Amberen. It also introduces a new natural menopause ingredient,
EstroG-100. EstroG-100 has a proven track record of safety and efficacy.“Menopause is tough enough as it is," says Michael Jeffers, Helios CORP/Sunbio CEO. “Women shouldn't have to put their health at risk to get through it with some comfort. A 2003 study shows that 80% of women turn to natural alternatives to help with the symptoms of menopause. Our goal in releasing the report is make sure women have the information they need to make a safe and reliable choice,” says Jeffers.
In 2002, the conventional treatment for menopause symptoms, hormone replacement therapy (HRT), came under fire when the Women's Health Initiative trial showed it increased women's risk for heart disease, breast cancer and stroke. Without this option, women have turned to natural alternatives.
However
§ In 2006, the U.K. and Australia required labeling for Black cohosh products warning about potential liver toxicity. In 2008, nonprofit standards and safety organization, US Pharmacopeia also made this recommendation. Denmark and Korea have banned its sale;
§ In 2007, a National Institute of Environmental Health study showed genistein, a soy isoflavone, to be carcinogenic in rats. Organizations like the North American Menopause Society and the Breast Cancer and Environmental Health Research Agency have called for more research on soy and genistein to clarify its efficacy and safety.
§ Research on the popular alternative Amberen shows that it raises estrogen levels above the levels achieved through HRT. No research has been done to clarify if it is safe for women worried about estrogen positive breast cancer.
Says geriatric physician Dr. Eunah Fisher, MD, FACP "I haven't had any patients who used genistein. But I have had many women try Black cohosh without relief of their symptoms. After the literature revealed some of the adverse events associated with Black cohosh and genistein, I began to discourage my patients from using them."
In contrast, EstroG-100, a combination of three botanicals drawn from traditional Korean medicine, offers women proven relief without risks. EstroG-100 has been proven efficacious through both Phase I and Phase II clinical trials. It has been proven safe through 5 toxicity tests and 2 liver toxicity tests. Two additional tests demonstrate EstroG-100 has no binding affinity for estrogen receptors alpha and beta.
As Dr. Nikos Linardarkis, MD, author of 10 Natural Ways To A Good Night's Sleep, points out "The research always changes and things come up. We didn’t have the ability to test for certain things like estrogen binding affinity 20 or 30 years ago. But now we do. So we should change. It doesn't make sense for women to take a product that has potential health risks. Why not use a good ingredient and a product that is safe?"
In addition to detailing concerns associated with products within the menopause category, the report raises some larger questions for the nutritional supplement industry.
"Unfortunately pharmaceutical drugs have redefined health and wellness, all in a very short period of time. But there should be well-researched, nutritional choices available to the consumer," explains Jeffers. "All Helios CORP/Sunbio ingredients undergo unbiased Phase I and Phase II clinical testing as well as thorough safety testing. This report challenges the nutritional supplement industry to consider the high road where safety and performance exist. Set the bar higher for the benefit of the consumer."
About Helios CORP/Sunbio
Helios CORP/Sunbio is a privately owned and global company that develops new ideas, science, and cultural remedies. These are translated into commercial applications for the benefit of manufacturers and consumers. Claims and representations are based on the information, data, clinical studies, and remedies as provided by our science and manufacturing partners.
For its diligent work in developing performance based and independently validated human clinical studies to support the use of natural products, Helios/ Sunbio was awarded the honor of Top Science Company at the natural products trade show, Expo West 2012. EstroG-100 was awarded the Top Branded Ingredient at Nutrition Business Journal Summit in 2007, and the Helios/ Sunbio ingredient, NC-518 for men and women’s bone density, won the Top Innovation Award at the 2011 Institute For Food Technology Expo.
Herbal Supplements Face New Scrutiny
Elderberry extract and acai to boost the immune system. Black cohosh to lessen the discomforts of menopause. Soy capsules to prevent bone loss and prostate cancer.Many botanical supplements—made from the seeds, bark, leaves, flowers and stems of a wide range of plants—have been widely used as folk remedies for centuries. Americans have been consuming growing quantities of the supplements in hopes of warding off disease and easing symptoms of various conditions. But there is scant scientific evidence to support their health benefits.
Usage of botanicals is growing.
"Sometimes people assume because a product is natural, it is also safer. But these compounds can have both benefits and potential side effects and we need to understand both of those," says Floyd Chilton III, director of the Center for Botanical Lipids and Inflammatory Disease Prevention at Wake Forest University Baptist Medical Center in Winston-Salem, N.C. Dr. Chilton's center received a $7.5 million federal grant to study botanicals, including whether plant oils such as echium and borage can help play a role in preventing cardiovascular disease, asthma and diabetes.
"People are using supplements for purposes for which they were not intended," such as treating health conditions they have self-diagnosed, or using multiple supplements in combination with prescription medications, says Marguerite Klein, director of the Botanical Centers Research program at the National Institutes of Health. One concern, she says is the heavy use by women of Black cohosh to treat menopause symptoms, such as hot flashes. Limited research seems to support the Black cohosh's benefit. But it isn't known how the botanical works. Black cohosh has been linked in some patients to liver damage, and breast-cancer patients are often advised to avoid using it because its effects on breast tissue are unknown.
Helping to spur the research initiative are the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, both part of the National Institutes of Health. The agencies last month awarded grants totaling about $37 million to five dietary supplement research centers, expanding a program that has already awarded more than $250 million in research grants for herbs and botanicals since 2002. The NIH is also funding research into botanical products through the National Cancer Institute, which is interested in how components in botanicals might influence cancer risk and tumor growth.
Unlike drugs, which must be tested in clinical trials and approved by the Food and Drug Administration before they can be marketed, botanicals and other supplements don't require regulatory approval. The FDA in June began requiring all supplement makers to follow strict quality manufacturing standards, but the agency only periodically inspects plants.
An investigation published in May by the General Accounting Office found deceptive marketing practices at a number of online retailers, including claims that supplements could prevent or cure conditions such as diabetes, cancer, or cardiovascular disease. The investigation also found trace amounts of potentially hazardous contaminants, such as lead or bacteria, in 37 of 40 herbal dietary supplement products it tested.
Tod Cooperman, president of ConsumerLab.com, which tests supplement brands for quality, says the group finds problems with about 25% of all supplements, and especially with herbal products, many with ingredients from overseas. A recent review of supplements made from ginseng—commonly taken to boost energy and vitality—found that 45% failed quality tests because they didn't contain the advertised amount of ginseng or were contaminated with lead. Test results and other information are available to members, who pay $30 annually.
Consumers also can find information about potential uses, benefits and risks of dietary supplements at federal websites ods.gov and nccam.gov. Another government site, Medlineplus.gov, grades scientific evidence on a variety of supplements.
William Cefalu, director of the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, says researchers are only beginning to understand how thousands of different compounds in a single plant may interact, and how the concentration of a particular plant chemical affects its potency. For example, peppermint tea is considered safe to drink, but peppermint oil, often taken for irritable bowel syndrome or indigestion, is much more concentrated and can be toxic if used in high doses.
Because the potency of wild plants can vary, some researchers are cultivating their own. At the Center for Botanical Interaction Studies at the University of Missouri in Columbia, 600 types of soybean seeds are being cultivated to study different concentrations of the same compounds in the plants and how they might work to prevent prostate cancer. The center is also growing 60 types of elderberries to study the plant's possible role in boosting the immune system against infection and fighting cancer and inflammation in the body. Center director Dennis Lubahn says there may be variations in individual plants that will make a difference in how well they fight disease. "We've come a long way from the traditional medicine woman sampling leaves in the forest," he says.
Petal Power?
Researchers are studying if plant-based supplements on the market can help treat many diseases and conditions.BOTANICAL | POSSIBLE BENEFIT | POSSIBLE RISKS |
Black cohosh | Prevention of hot flashes and other menopause symptoms, may help improve bone density. | No long-term safety data on breast tissue; may cause liver damage. |
Soy (phytoestrogens) | May lower risk of LDL ('bad') cholesterol; reduce hot flashes and other menopause symptoms. | Possible role in development of breast, uterine cancers. |
Milk thistle | May promote growth of liver cells, improve symptoms of liver disease; possible treatment for hepatitis C. | May lower blood-sugar levels in diabetics; allergic reactions, gastrointestinal side effects. |
Ginseng | May lower blood sugar, boost immunity, increase stamina. | Headaches; allergic reactions; sleep and gastrointestinal problems. |
Elderberry | Anti-oxidant, may lower cholesterol, boost immune system, improve heart health. | Diuretic effects; no scientific data on benefits. |
Cranberry (extracts, tablet, capsules ) | May prevent urinary tract disorders, stomach ulcers, dental plaque; anti-cancer benefits. | Could cause GI upset; may interact with blood-thinning drugs. |
Evening primrose | Modest benefits for eczema; may be useful for rheumatoid arthritis and breast pain. | May cause gastrointestinal upset, headache. |
St. John's wort | May help treat mild depression. | May limit effectiveness of prescription medications; unproven as treatment for major depression. |
Readers may wonder why I've chosen this title, especially when it's part of the Drug Dangers series. My answer: it's like watching a Michael Moore movie--although it's biased and the one-sided research is sloppy, it brings up some good points.
According to the National Center for Complementary and Alternative Medicine(NCCAM), about 38 percent of American adults use a form of complementary or alternative medicine. However, some people assume that "natural" means "safe". The author, Judy Monroe, presents the overused but valid arsenic argument.
"Just because something is natural does not mean it is good for you or that it will not harm you," she writes. "Arsenic and hemlock are natural, but both are strong, potentially deadly poisons."
The argument is not exactly phrased well. No one in their right mind would use arsenic or hemlock. However, wormwood is sometimes used as an alternative medicine or recreational substance, and it is poisonous.
Monroe points out that the wrong herb, or the wrong part of the right herb, can be dangerous. For example, rhubarb stems are used in medicine. According to Wikipedia, rhubarb is a strong laxative, astringent and possibly useful for lowering blood sugar. The leaves, however, are poisonous, and there is debate about whether or not it is safe to eat the raw stalks (I said "safe", not "enjoyable").
A point she mentions that probably can not be overemphasized is that dietary supplements are not regulated by the Food and Drug Administration (FDA). That means that companies do not have to prove their product is effective or even safe. The companies can make claims, as long as they include the warning "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
An example is kava. According to NCCAM, this member of the pepper family is used to help fight insomnia, treat asthma, treat urinary tract infections, a topical numbing agent, an anti-anxiety treatment and treatment for menopause symptoms. However, the FDA warns that kava may increase a patient's risk of severe liver damage, and NCCAM-funded studies have been suspended. It remains on the market.
Another problem Monroe mentions is the lack of regulatory standards. She cites a 1995 Consumer Reports study on ginseng products. The study "found a wide variation, from brand to brand ... Some pills had 10 to 20 times as much others, and one brand had very little ginsenoside [the active ingredient in ginseng]."
A third problem is labeling. Simply put, what is on the label is not always what is in the product. All you have to do to see examples is go to NCCAM's web page and read "Alerts and Advisories".
Monroe helpfully offers advice for people who wish to use herbal remedies. Her recommendations are:
Buy only herbals whose labels identify the plants and explain when not to use the herb.Stick with a reliable brand.
Remember that herbal extracts are much stronger than whole herbs.
Research herbal remedies. Anything that sounds too good to be true probably is. The most reliable web sites on herbal remedies are run by the government, universities and hospitals.
Avoid remedies that are much cheaper than the competing brands; this probably means the company has substituted the herb with an inferior ingredient.
Look for the United States Parmacopeia notation.
Any adverse effects to herbal remedies should be reported to the FDA's MedWatch program. This can be done online, or by calling 1-800-FDA-1088.
=============================
Products should not be used in children under 12 years old
MHRA - Medicines and Healthcare products Regulatory Agency20 Aug 2012 | Press release: Echinacea herbal
Date: | Monday 20 August | |
Time: | 12:30 | |
Subject: | Echinacea herbal products should not be used in children under 12 years old | |
Contact: | Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
This move by the MHRA follows precautionary advice from the European Herbal Medicinal Products Committee (HMPC) and from the UK Herbal Medicines Advisory Committee (HMAC). They both concluded that the perceived benefits of the use of Echinacea in children under 12 years are outweighed by the potential risks in this age-group and there is a low risk of allergic reactions but these could be severe. Children aged 12 years or over and adults can continue to use oral products containing Echinacea. Risks of side effects in older children and adults are reduced because they weigh more and in general catch fewer colds.
Two Echinacea products (Echinaforce Junior Cold & Flu Tablets and Echinaforce Chewable Cold & Flu Tablets) were registered under the Traditional Herbal Registration (THR) Scheme for children aged between six and 12 years as well as for older children and adults. These products have been updated in line with this new advice and newly labelled products will be available in due course. Current stock will be over-labelled and the new labels will state clearly that the products should not be used in children under 12 years.
In addition, there were two oral Echinacea products (Echinaforce Tablets and Echinaforce Echinacea Drops) with product licences for children aged between six and 12 years. The labelling of these products is also being updated in line with this advice and existing stocks will also be over-labelled.
However, there is an unknown number of unlicensed Echinacea products on sale in the UK. The MHRA is requesting that these products are also relabelled and advises parents and carers not to use them in children under 12 years.
Richard Woodfield, the MHRA's Head of Herbal Policy, said:
"This is not a serious safety issue, but parents and carers need to be aware that children under 12 could have a low risk of developing allergic reactions, such as rashes from oral Echinacea products
"The MHRA is working with the herbal sector to ensure that all oral Echinacea products are re-labelled with a warning that they should not be given to children under 12. The measures being taken are precautionary in nature. Parents should not worry if they have given Echinacea to children under 12 in the past. Anyone who has concerns should speak to their doctor, pharmacist or qualified healthcare practitioner."
Notes to Editor
1. The product information for authorised Echinacea products lists the following allergic reactions: rashes, hives, swelling including swelling of the skin due to fluid and swelling of the face, difficulty breathing, asthma and life threatening anaphylactic shock.
2. The two products with product licences are called:
Echinaforce Tablets (PL 13668/0001) and
Echinaforce Echinacea Drops (PL 13668/0002)
And the two products with traditional herbal registrations are called:
Echinaforce Junior Cold & Flu Tablets (THR 13668/0015) and
Echinaforce Chewable Cold & Flu Tablets (THR 13668/0025)
3. Information on the advice from European Herbal Medicinal Products Committee (HMPC) can be found here: Herbal medicines for human use
4. Information on the Traditional Herbal Registration (THR) Scheme can be found here:
Herbal medicines regulation: Registered traditional herbal medicines
5. Information on the herbal products registered under the Traditional Herbal Registration (THR) Scheme can be found here: List of products granted a Traditional Herbal Registration (THR)
6. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Our work is underpinned by robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
Experts warn herbal remedy butterbur can cause liver damage and even organ failure
By Lauren Paxman
Dangerous remedy: No products containing
butterbur (pictured) have been sanctioned for use in Britain, but they
are still being advertised here
But if they contain an unlicensed ingredient called butterbur, they could cause serious liver damage or even organ failure, experts have warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) has urged British herbal shops to remove products containing butterbur - also called Petasites hybridus - from their shelves.
Butterbur is normally used to treat migraines, but it contains pyrrolizidine alkaloids, which studies have shown can cause serious liver damage and organ failure.
Currently, no products containing the ingredient have been sanctioned for use in Britain under the Traditional Herbal Registration Scheme. Several other European countries have also banned it.
However, the MHRA said products containing butterbur are currently being marketed in the UK. And while no adverse reactions to it have been reported here, cases of liver toxicity have been reported elsewhere in Europe.
The MHRA advised people who take herbal remedies to check products for a THR number on the label, which shows that they have been licensed for use in the UK.
MHRA head of herbal policy Richard Woodfield said: 'We advise anyone taking these products to stop doing so.
'If you have any concerns, speak to your GP or pharmacist. If you think you have suffered a side effect from these products, tell us through our reporting system called the Yellow Card Scheme.
Short-term solution, long-term problem:
Butterbur is normally used to treat migraines, but it contains
pyrrolizidine alkaloids, which studies have shown can cause serious
liver damage and organ failure.
'Some unlicensed herbal medicines can pose a serious risk to your health. We will continue to take regulatory action against herbal medicines not marketed within the Traditional Herbal Registration Scheme.'
Herbal weight loss pill warning
People are being warned to stop using a weight loss pill sold over the internet and in Chinese medicine shops.
The Medicine and Healthcare products Regulatory Agency (MHRA) has issued a warning about Herbal Flos Lonicerae (Herbal Xenicol).Anyone taking the product should stop immediately and contact a doctor, it says.
The warning comes after reports of side effects such as palpitations, with one patient needing hospital treatment.
The capsules are thought to contain an as yet unknown pharmaceutical substance.
Tests are underway to establish the cause of the side effects.
New standards By April this year, under a European directive, all manufactured herbal medicines will have to be registered under a new scheme to prove they meet safety and quality standards.
The scheme is known as the Traditional Herbal Registration (THR).
Richard Woodfield, head of herbal medicines policy at the MHRA, said: "Since 2005, the MHRA has found over 280 examples where so-called 'herbal' or 'natural' products have been adulterated with random quantities of powerful pharmaceutical substances. Such products pose a real risk to the public.
"It is situations such as this one that the THR scheme is being introduced and why EU legislation has been changed in order to regulate herbal medicines.
"People have a right to know that what they are putting into their bodies to treat one condition will not directly cause a possibly more severe one simply as a result of very poor practice in parts of the sector.
"The THR scheme will make it possible to give people clear advice on which herbal products are safe to use, and provide an assurance that they were made in adequate conditions, and to the necessary standard."
Risks of mixing drugs and
herbal supplements: What doctors and patients need to know
May 1, 2012 in Health
Risks of mixing drugs and herbal supplements: What doctors and patients
need to know
Alternative and Complementary Therapies is a bimonthly journal that
publishes original articles, reviews, and commentaries evaluating
alternative therapies and how they can be integrated into clinical
practice. Credit: ©2012 Mary Ann Liebert Inc., publishers
Herbal, dietary, and energy or nutritional supplements may offer
specific health benefits, but they can also have harmful and even
life-threatening effects when combined with commonly used medications.
Clinicians need to be aware of and educate their patients about the
potential risks of mixing supplements and therapeutic agents, since
their interaction can diminish or increase drug levels. This timely
topic is explored in a provocative article in Alternative and
Complementary Therapies, published by Mary Ann Liebert, Inc. The article
is available free on the Alternative and Complementary Therapies
website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Herbal, dietary, and energy
or nutritional supplements may offer specific health benefits, but they
can also have harmful and even life-threatening effects when combined
with commonly used medications. Clinicians need to be aware of and
educate their patients about the potential risks of mixing supplements
and therapeutic agents, since their interaction can diminish or increase
drug levels. This timely topic is explored in a provocative article in
Alternative and Complementary Therapies, published by Mary Ann Liebert,
Inc. The article is available free on the Alternative and Complementary
Therapies website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc search and more info website
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Herbal, dietary, and energy
or nutritional supplements may offer specific health benefits, but they
can also have harmful and even life-threatening effects when combined
with commonly used medications. Clinicians need to be aware of and
educate their patients about the potential risks of mixing supplements
and therapeutic agents, since their interaction can diminish or increase
drug levels. This timely topic is explored in a provocative article in
Alternative and Complementary Therapies, published by Mary Ann Liebert,
Inc. The article is available free on the Alternative and Complementary
Therapies website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc search and more info website
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Risks of mixing drugs and
herbal supplements: What doctors and patients need to know
May 1, 2012 in Health
Risks of mixing drugs and herbal supplements: What doctors and patients
need to know
Alternative and Complementary Therapies is a bimonthly journal that
publishes original articles, reviews, and commentaries evaluating
alternative therapies and how they can be integrated into clinical
practice. Credit: ©2012 Mary Ann Liebert Inc., publishers
Herbal, dietary, and energy or nutritional supplements may offer
specific health benefits, but they can also have harmful and even
life-threatening effects when combined with commonly used medications.
Clinicians need to be aware of and educate their patients about the
potential risks of mixing supplements and therapeutic agents, since
their interaction can diminish or increase drug levels. This timely
topic is explored in a provocative article in Alternative and
Complementary Therapies, published by Mary Ann Liebert, Inc. The article
is available free on the Alternative and Complementary Therapies
website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc search and more info website
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Risks of mixing drugs and
herbal supplements: What doctors and patients need to know
May 1, 2012 in Health
Risks of mixing drugs and herbal supplements: What doctors and patients
need to know
Alternative and Complementary Therapies is a bimonthly journal that
publishes original articles, reviews, and commentaries evaluating
alternative therapies and how they can be integrated into clinical
practice. Credit: ©2012 Mary Ann Liebert Inc., publishers
Herbal, dietary, and energy or nutritional supplements may offer
specific health benefits, but they can also have harmful and even
life-threatening effects when combined with commonly used medications.
Clinicians need to be aware of and educate their patients about the
potential risks of mixing supplements and therapeutic agents, since
their interaction can diminish or increase drug levels. This timely
topic is explored in a provocative article in Alternative and
Complementary Therapies, published by Mary Ann Liebert, Inc. The article
is available free on the Alternative and Complementary Therapies
website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc search and more info website
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Risks of mixing drugs and
herbal supplements: What doctors and patients need to know
May 1, 2012 in Health
Risks of mixing drugs and herbal supplements: What doctors and patients
need to know
Alternative and Complementary Therapies is a bimonthly journal that
publishes original articles, reviews, and commentaries evaluating
alternative therapies and how they can be integrated into clinical
practice. Credit: ©2012 Mary Ann Liebert Inc., publishers
Herbal, dietary, and energy or nutritional supplements may offer
specific health benefits, but they can also have harmful and even
life-threatening effects when combined with commonly used medications.
Clinicians need to be aware of and educate their patients about the
potential risks of mixing supplements and therapeutic agents, since
their interaction can diminish or increase drug levels. This timely
topic is explored in a provocative article in Alternative and
Complementary Therapies, published by Mary Ann Liebert, Inc. The article
is available free on the Alternative and Complementary Therapies
website at www.liebertpub.com/act.
"'Natural' does not equal 'safe,'" and the effects and interactions of
herbal or dietary supplements and functional foods such as energy drinks
or nutritional bars can be difficult to predict, says Catherine
Ulbricht, PharmD, co-founder of Natural Standard Research Collaboration
and Senior Attending Pharmacist at Massachusetts General Hospital
(Boston, MA). "If something has a therapeutic action in a human body,
this substance can also cause a reaction or an interaction."
The risk for interactions is greatest in younger and older people and in
individuals with multiple health conditions or who take multiple
medications, explains Dr. Ulbricht in the article "What Every Clinician
Should Know About Herb–Supplement–Drug Interactions." She describes in
detail some of the most common side effects that result from
interactions between herbal supplements and therapeutic drugs, and
provides guidance to clinicians on how to decrease the risk of harmful
interactions in their patients and what resources are available for
obtaining accurate information and reporting patient reactions.
Common examples include an increased risk of significant bleeding
associated with garlic, ginkgo, ginger, and saw palmetto supplements;
decreased blood sugar as a result of chromium, cinnamon, whey protein,
and others; hormonal effects of dong quai, black cohosh, kudzu, and saw
palmetto; and elevated blood pressure caused by bloodroot, green tea,
hawthorn, and maté.
Provided by Mary Ann Liebert, Inc search and more info website
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
Read more at: http://medicalxpress.com/news/2012-05-drugs-herbal-supplements-doctors-patients.html#jCp
======================
Popular herbal supplement used to treat prostate pain 'does not work', say experts
By Jenny Hope
No benefit: A study into herbal remedy saw
palmetto found that even a trebling of the dosage does not help men with
prostate problems
Thousands of men take the remedy saw palmetto, which comes from the fruit of a type of palm tree, to improve urinary problems caused by benign prostatic hyperplasia (BPH).
But a new study found even taking three times the standard dose of the supplement produced no benefit.
Many older men take saw palmetto capsules bought from health food shops or on the internet as a first option when they are diagnosed, before drugs to make the prostate shrink or surgery.
It is the most popular supplement for BPH, and part of a growing £396 million a year market in health supplements.
The latest US research involved more than 300 men aged 45 and older who had moderate symptoms of a swollen prostate, including frequent urination and difficulty emptying their bladders.
They were randomly selected to receive a daily saw palmetto supplement or a ‘dummy’ placebo capsule that smelled and tasted the same.
After 24 weeks the saw palmetto dosage was increased from 320 milligrams to 640 milligrams. This was raised again to 960 milligrams 24 weeks later.
At the end of nearly 17 months, men taking the supplement and the placebo were still suffering identical symptoms.
Neither group of men knew who was taking the herbal remedy until the study was completed, according to results published in the Journal of the American Medical Association.
Study leader Professor Gerald Andriole, from the Washington University School of Medicine in St Louis, said ‘Now we know that even very high doses of saw palmetto make absolutely no difference.
Traditional remedy: Saw palmetto uses berries from a US palm, pictured, in capsules, tablets, liquids and teas
Prof Andriole said there was no benefit to taking the supplement compared with the dummy treatment, and it had no greater effect on symptoms.
Earlier studies have produced conflicting results, although Professor Edzard Ernst, Britain’s first professor of complementary medicine, recently said there was evidence to support its use.
Saw palmetto, which uses berries from a US palm in capsules, tablets, liquids and teas, has been registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a traditional herbal remedy to help relieve symptoms from an enlarged prostate.
However, registration is based on traditional use rather than the results of clinical studies.
======================
Traditional Chinese medicine found to have potentially toxic ingredients
Chinese herbal medicinesApril 18, 2012By: Harold Mandel
As the interest in natural health care becomes more widespread there has been a growing use of Traditional Chinese Medicines. And so there has been deep concerns among users of natural health care supplements in Syracuse over new research which has shown that many Traditional Chinese Medicines may contain potentially toxic ingredients. Nutrition Horizon has reported "Illegal and Potentially Toxic Ingredients Found in Traditional Chinese Medicines." Researchers at Murdoch University for the first time have used new DNA sequencing technology to reveal the animal and plant composition of traditional Chinese medicines (TCM), with results which have raised concerns.
Dr Mike Bunce, the research leader, has said that some TCMs contained potentially toxic plant ingredients, allergens and even traces of endangered animals. Dr Bunce said “TCMs have a long cultural history but today, consumers need to be aware of the legal and health safety issues before adopting them as a treatment option.” Fifteen TCM samples, in the form of powders, tablets, capsules, flakes and herbal teas were audited using the DNA preserved in the samples. The results of this study have been published in the journal PLoS Genetics. Dr Bunce has said “In total we found 68 different plant families in the medicines – they are complex mixtures of species. Some of the TCMs contained plants of the genus Ephedra and Asarum.
These plants contain chemicals which can be toxic if the wrong dosage is taken, but none of them actually listed concentrations on the packaging. We also found traces from trade restricted animals that are classified as vulnerable, endangered, or critically endangered, including the Asiatic black bear and Saiga Antelope.” Prior to this time it has been difficult to determine the biological origins of ingredients which are contained within TCMs because processing into pills and powders makes identification difficult. PhD student Megan Coghlan has said this research shows that second-generation, high throughput sequencing is an efficient and cost-effective way to audit the species composition.
Another serious concern has been the mislabeling of TCMs wherein consumers are unaware of the presence of some ingredients including animal DNA and potential allergens such as soy or nuts. Dr Bunce said “A product labeled as 100 per cent Saiga antelope contained considerable quantities of goat and sheep DNA. Another product, Mongnan Tianbao pills, contained deer and cow DNA, the latter of which may violate religious or cultural strictures.” The use of incorrect labels makes it difficult to enforce legislation and to prosecute cases of illegal trade. Dr Bunce has commented “It is hoped that this new approach to genetically audit medicinal products will bring about a new level of regulation to the area of complementary and alternative medicine.”
----------------------------------------
Herbal medicines from China contain poison and elements from endangered species
herbal medicine April 17, 2012 By: Suzanne Albrecht
Imported Chinese herbal products were found to have ingredients from endangered animals, substances from toxic plants, and material from livestock. Most of these ingredients were not listed on the label. A genetic study done by Australian scientists uncovered these substances in products being imported into Australia. They tested 15 products, including powders, capsules, bile flakes, or herbal teas.
Because of the complex formulation and combination of many substances in Chinese medicinal products, it is difficult for researchers to identify the constituents. These Australian researchers used a technology that allowed them to determine many DNA sequences in the test products. These sequences were then entered into a database which allowed them to identify substances that may have gone unnoticed.
They found an herb called Ephedra (removed from the market in the US approximately 7 years ago) and Aristolochia (contains an ingredient that can cause kidney and liver damage). They also found genetic material from the Saiga antelope (endangered) and the Asian black bear, which is classified as vulnerable. In addition, material from water buffaloes, cows, and goats were found.
Chinese herbal medicine has been used in China for over 3000 years. In the past couple of decades, use outside of China has been growing in popularity. These herbal concoctions have been used in conjunction with Western medicine or as an alternative to Western medicine.
Herbal medicine is a billion dollar industry. Many people believe that natural substances are safer than manufactured prescription and over-the-counter drugs. However, unlike medications manufactured by pharmaceutical companies, herbal and natural supplements are not rigorously regulated by the Food and Drug Administration (FDA).
Undeclared ingredients and contaminants are discovered all the time, but usually after many people have purchased and consumed the product. Contaminants that have been found in Chinese medicinal products include allergenic substances, plant toxins, heavy metals (mercury, lead, copper, and arsenic), and active drugs of unknown concentration.
A recent example is the discovery of sibutramine in a product called SlimXtreme. Although SlimXtreme is not a Chinese product, it is a dietary supplement that slips through the safety net of rigorous FDA regulation. Upon a routine inspection of this product the FDA found sibutramine.
Sibutramine is the active ingredient in a drug called Meridia. Meridia was withdrawn from the market due to adverse effects, which even included death. The drug increased blood pressure and caused heart attacks and strokes.
Herbal and natural supplements are not necessarily safer. They can contain dangerous substances or nothing medicinal at all. The public needs to be aware that these products are not stringently regulated and may pose a health risk.
New research reveals danger of combining warfarin with herbal and dietary supplements November 15, 2010 Herbal and dietary supplements are popular. People claim they make their joints feel better, their bones stronger, and their hearts healthier. But a recent study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City shows that many of these people may not realize their favorite supplement, mixed with prescription medications, may be putting their lives in danger, especially if they are taking warfarin – a blood-thinning medication commonly prescribed to patients living with atrial fibrillation to lower their risk of stroke. Researchers and pharmacists from the Intermountain Medical Center Heart Institute, along with registered dieticians from Utah State University, conducted interviews with 100 atrial fibrillation patients to determine their understanding of potential interactions between supplements and medications, such as warfarin. Warfarin is a commonly prescribed drug used to prevent blood clots from forming. It is prescribed for people with certain types of irregular heartbeat, people with prosthetic heart valves, and people who have suffered a heart attack. Warfarin is also commonly used to treat or prevent venous thrombosis and pulmonary embolism. Researchers found that of 35 patients combining warfarin with supplements, more than half (54 percent) were unaware of potential interactions. Researchers also found that of the 100 most-used supplements, 69 percent interfere with the effectiveness of warfarin. The most commonly used herbal and dietary supplements among a-fib patients were: supplemental vitamins, glucosamine/chondroitin, fish oil and coenzyme Q10. Researchers will present their findings at the American Health Association's annual scientific session in Chicago on Monday, Nov. 15. "This is an alarming finding," said T. Jared Bunch, MD, a study author and heart rhythm specialist at the Intermountain Medical Center Heart Institute. Warfarin and herbal and dietary supplements "compete" in the liver. This competition changes the way the blood thinner works – either intensifying its active ingredients, thereby increasing the risk of bleeding, or by reducing its effectiveness, increasing the risk of stroke, he said. "This data is important because it demonstrates how important it is for physicians to understand our patients' knowledge about and use of these products," said Dr. Bunch. "We need to do a better job of teaching our patients about the dangers of mixing warfarin with these products." Those taking herbal and dietary supplements often experienced worse outcomes, possibly attributable to drug interaction, said Dr. Bunch. For example, those who take supplements reported higher rates of unexplained bleeding (23 percent vs. 17 percent) and a greater need for blood transfusions (14 percent vs. 10 percent). Two other notable findings suggest lack of understanding about warfarin use: Patients who reported taking supplements were more likely to skip their warfarin (34 percent to 17 percent) or take extra doses when it was missed. "We have also learned that – for whatever reason – patients don't want to tell their doctors that they are taking herbal and dietary supplements," Dr. Bunch said. "Physicians must be active in asking about supplement use and not place responsibility on patients. We need to tell our patients that it's acceptable to use herbal and drug supplements, but important for them to tell us so that we can educate them about the benefits, dangers, and potential interactions with their other medications." Provided by Intermountain Medical Center
New research reveals danger of combining warfarin with herbal and dietary supplements November 15, 2010
Herbal and dietary supplements are popular. People claim they make their joints feel better, their bones stronger, and their hearts healthier. But a recent study by researchers at the Intermountain Medical Center Heart Institute in Salt Lake City shows that many of these people may not realize their favorite supplement, mixed with prescription medications, may be putting their lives in danger, especially if they are taking warfarin – a blood-thinning medication commonly prescribed to patients living with atrial fibrillation to lower their risk of stroke. Researchers and pharmacists from the Intermountain Medical Center Heart Institute, along with registered dieticians from Utah State University, conducted interviews with 100 atrial fibrillation patients to determine their understanding of potential interactions between supplements and medications, such as warfarin. Warfarin is a commonly prescribed drug used to prevent blood clots from forming. It is prescribed for people with certain types of irregular heartbeat, people with prosthetic heart valves, and people who have suffered a heart attack. Warfarin is also commonly used to treat or prevent venous thrombosis and pulmonary embolism. Researchers found that of 35 patients combining warfarin with supplements, more than half (54 percent) were unaware of potential interactions. Researchers also found that of the 100 most-used supplements, 69 percent interfere with the effectiveness of warfarin. The most commonly used herbal and dietary supplements among a-fib patients were: supplemental vitamins, glucosamine/chondroitin, fish oil and coenzyme Q10. Researchers will present their findings at the American Health Association's annual scientific session in Chicago on Monday, Nov. 15. "This is an alarming finding," said T. Jared Bunch, MD, a study author and heart rhythm specialist at the Intermountain Medical Center Heart Institute. Warfarin and herbal and dietary supplements "compete" in the liver. This competition changes the way the blood thinner works – either intensifying its active ingredients, thereby increasing the risk of bleeding, or by reducing its effectiveness, increasing the risk of stroke, he said. "This data is important because it demonstrates how important it is for physicians to understand our patients' knowledge about and use of these products," said Dr. Bunch. "We need to do a better job of teaching our patients about the dangers of mixing warfarin with these products." Those taking herbal and dietary supplements often experienced worse outcomes, possibly attributable to drug interaction, said Dr. Bunch. For example, those who take supplements reported higher rates of unexplained bleeding (23 percent vs. 17 percent) and a greater need for blood transfusions (14 percent vs. 10 percent). Two other notable findings suggest lack of understanding about warfarin use: Patients who reported taking supplements were more likely to skip their warfarin (34 percent to 17 percent) or take extra doses when it was missed. "We have also learned that – for whatever reason – patients don't want to tell their doctors that they are taking herbal and dietary supplements," Dr. Bunch said. "Physicians must be active in asking about supplement use and not place responsibility on patients. We need to tell our patients that it's acceptable to use herbal and drug supplements, but important for them to tell us so that we can educate them about the benefits, dangers, and potential interactions with their other medications."
Provided by Intermountain Medical Center
=======================
Side Effects of Natural Supplements
Jul 18, 2011 | By Linda Tarr Kent
Natural supplements are useful for a variety of purposes, from helping alleviate premenstrual syndrome to boosting heart health. Just because a supplement is natural, however, doesn't make it safe for everyone to use. Supplements do have side effects -- even if they are natural -- and also interact with medicines. Always consult a doctor before trying a new supplement.
Gastrointestinal Problems
Many supplements can cause gastrointestinal symptoms such as diarrhea or nausea and vomiting. Those that may cause diarrhea include Asian and American ginseng, cat's claw, black cohosh, lobelia, green tea, feverfew, peppermint, goldenseal and milk thistle. Herbs that may make you nauseous or cause vomiting include Asian and American ginseng, Siberian ginseng, arnica, barberry, evening primrose, black cohosh, feverfew, green tea, goldenseal, evening primrose, hawthorn, lavender, kava kava, milk thistle, lobelia, German and Roman chamomile, pau d'arco, passionflower, rosemary and uva ursi.
Hormonal Effects
Some herbs may affect your hormone levels, such as chasteberry. That means you should avoid such herbs if you are taking birth control pills, pregnant or have a hormone-sensitive condition like breast cancer, according to the National Center for Complementary and Alternative Medicine. Other herbs that have estrogenic activity include alfalfa, black cohosh, flax, licorice, hops, soy and red clover.
Liver Damage
Using supplements such as uva ursi may cause liver damage, according to the University of Maryland Medical Center. Other supplements that have destructive effects on your liver include bishop's weed, chaparral, borage, coenzyme Q10, niacin, comfrey, valerian and red yeast rice, according to "The Essential Herb-Drug-Vitamin Interaction Guide," by George T. Grossberg and Barry Fox.
Drug Interactions
Supplements often interact with medications. Marshmallow, for example, can hamper absorption of medicine. Garlic and many other herbs can thin your blood and raise your risk of bleeding or bruising, especially if taken with blood-thinning medicines such as warfarin. Other herbs, such as bitter melon and fenugreek, can lower your blood-glucose levels, so use them with caution if you take diabetes medication. Supplements also can worsen side effects from medication. Dandelion, for example, can increase side effects from lithium. Some herbs are dangerous to take with certain medicines. For example, do not combine herbs that contain cardiac glycosides such as hedge mustard, adonis, digitalis and squill with medication that also contains cardiac glycosides because this can lead to arrhythmias, heart failure and death, say Grossberg and Fox. Some herbal supplements, such as those containing grapefruit, can change the way that drugs are metabolized in your body and potentially raise the amount in your body to a dangerous level.
Other Effects
Natural supplements can cause a variety of other side effects, from sensitivity to the sun to possibly fatal allergic reactions. Other common side effects from herbal supplements include potassium depletion, diuretic action, sedation, laxative action, stimulant effects, alterations in thyroid function, dizziness, headaches, changes in blood pressure, muscle cramps, skin rashes and fatigue. Some supplements like ginkgo biloba also raise your risk for seizures.
References
University of Maryland Medical Center: Herbs With Similar Effects as Goldenseal
University of Maryland Medical Center: Herbs With Similar Effects as German Chamomile
National Center for Complementary and Alternative Medicine; Chasteberry; July 2010
"The Essential Herb-Drug-Vitamin Interaction Guide"; George T. Grossberg and Barry Fox; 2007
University of Maryland Medical Center; Uva Ursi; March 2010
University of Maryland Medical Center; Marshmallow; March 2009
Article reviewed by Eric Lochridge Last updated on: Jul 18, 2011
===================================================
The Side Effects of Slim-Xtreme Herbal Supplement
Aug 22, 2011 | By Tricia McMillan
Slim-Xtreme is an herbal weight loss supplement -- like any supplement, it is not regulated by the U.S. Food and Drug Administration. That means that it has not been proven effective, and there's no guarantee that the ingredients listed on the label are actually in the pills. In fact, Slim-Xtreme was recalled by the FDA in May 2011 for containing undeclared sibutramine, an appetite suppressant that was banned in the United States because it increased the risk of heart attack and stroke. The supplement's remaining ingredients are legal, but still pose a risk.
Stimulant
When ephedra was banned by the FDA in 2004, supplement makers scrambled to find a replacement of equal effectiveness for weight loss and found bitter orange. Bitter orange is related to ephedra, but unfortunately, it carries many of the same risks. According to Mayo Clinic nutritionist Katherine Zeratsky, bitter orange increases your heart rate and blood pressure, putting you at risk for fainting and migraines and increasing your risk of heart attack and stroke. These side effects are amplified when bitter orange is used at the same time as caffeine or other stimulants.
Diuretics
According to the Slim-Xtreme website, the ingredient Semen coicis is included in the formula for its diuretic effect. Diuretics flush excess fluid from your body by making you urinate more. You may lose a couple of pounds of water weight, but it will return when you drink more water. Diuretics can be dangerous when taken every day because they increase your risk of dehydration and can cause thirst, cramps, dizziness and headaches. More serious and long-term side effects include increased blood sugar and cholesterol, gout, impotence, menstrual problems and male breast enlargement.
Laxatives
Slim-Xtreme contains a whopping seven separate laxative ingredients. Increasing your bowel movements does not make you lose weight, other than the weight of the stool itself. By the time food is able to be excreted as stool, your body has already digested the nutrients -- and calories -- it contains. More importantly, daily laxative use can cause diarrhea, which furthers your risk of dehydration. When your bowels are artificially stimulated daily, they eventually forget how to move the stool through naturally, and you eventually cannot have a bowel movement without a laxative. Laxative dependence is a major problem that can cause permanent intestinal damage. Laxative overuse can also cause nausea, vomiting and severe cramps.
Caution
Slim-Xtreme is unlikely to cause fat loss. The ingredients are all herbal, but they can still pose a safety threat. Do not use these pills if you are pregnant, nursing, taking medications or other supplements or have a medical condition. In all cases, consult your doctor before use. Slim-Xtreme is formulated to increase your energy and increase your urination and bowel movements -- all of which can be accomplished more safely and effectively with a healthy diet and regular exercise.
References
SlimXtreme
U.S. Food and Drug Administration; Slim Xtreme Herbal Slimming Capsule; Undeclared Drug Ingredient; May 2011
MedlinePlus: Sibutramine
MayoClinic.com; Bitter Orange Weight Loss Supplements: Do They Work?; Katherine Zeratsky; November 2009
MayoClinic.com; Diuretics; December 2010
MedlinePlus: Stimulant Laxatives
Article reviewed by CarmenN Last updated on: Aug 22, 2011
=======================================
Sub Q Dietary Supplement Side Effects
Jul 17, 2011 | By Brian Willett
Sub Q is a weight loss supplement manufactured by Fusion Bodybuilding, a sports nutrition company that makes a variety of bodybuilding supplements. Sub Q is intended to enhance your weight loss efforts and promote increased fat loss thanks to its blend of herbal ingredients and stimulants. These ingredients may aid in weight loss, but some may put you at risk for side effects. Consult a doctor prior to using Sub Q or any other dietary supplements.
Headaches
Supplementing your workout plan and reduced-calorie diet with the Sub Q supplement may result in headaches. The product contains forskolin, an herbal extract purported to aid in weight loss but which may cause headaches. Additionally, Sub Q contains caffeine, and overconsumption of this stimulant can also promote headaches.
Dehydration
The Sub Q dietary supplement contains Taraxacum officinale, also known as dandelion. This herbal extract provides a number of vitamins and minerals, but it also acts as a diuretic, meaning it flushes water from your body. Caffeine also has diuretic properties, and the combination of these two ingredients with exercise may increase your risk of dehydration.
Depression
Fusion Bodybuilding's Sub Q dietary supplement contains isoleucine, valine and leucine, a group of amino acids purported to aid in muscle retention when dieting. However, research published in the February 2006 edition of the journal "Neuropsychopharmacology" found that isoleucine may reduce levels of dopamine in your brain. Low levels of dopamine are a major cause of depression.
Anxiety
Using the Sub Q dietary supplement may increase feelings of anxiety, as high levels of caffeine can promote feelings of nervousness. If you consume other caffeinated products, foods or drinks along with Sub Q, this effect may be exacerbated. Each serving of Sub Q provides 201 mg of caffeine, which is nearly six times the amount in a 12 oz. can of cola.
References
Fusion Bodybuilding: Sub Q
Memorial Sloan-Kettering Cancer Center; Forskolin; March 2011
Drugs.com: Caffeine Side Effects
University of Maryland Medical Center; Dandelion; December 2008
"Neuropsychopharmacology"; Effect of Acute Tyrosine Depletion in Using a Branched Chain Amino-Acid Mixture on Dopamine Neurotransmission in the Rat Brain; M. Le Masurier, et al.; February 2006
Mayo Clinic; Caffeine Content for Coffee, Tea, Soda and More; October 2009
Article reviewed by CarmenN Last updated on: Jul 17, 2011
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Herbal Uses of Clematis
Jun 7, 2011 | By Melissa Lind
Clematis is a climbing vine in the buttercup family. There are more than 200 clematis species in the world, which are mainly found in Asia and North America. Though some species are grown for the attractive flowers, a few have been used in folk and traditional Chinese medicine as herbal remedies. It has also been used as a Bach flower remedy. When taken internally, clematis may cause a number of side effects and some species may be toxic. As with all herbal supplements, consult a qualified healthcare professional before use.
Bach Flower Remedy Uses
The Bach Centre states that clematis is useful for people who exist in a dreamlike state. It may be used to help bring people back to earth so that they may accomplish their goals. Bach flower remedies are generally purchased in concentrated drops. A few drops are placed in a glass of water and drunk after dilution or a few drops are placed directly on the tongue. Clematis is also one of the ingredients in Bach's original crisis formula, which claims to clear the brain during crisis. Some natural healthcare practitioners also recommend using lamp diffusers or candles with the herb's essential oil in them. Bach remedies do not usually have any clinical research backing their effectiveness.
Skin Disorders
Although no clinical studies have been shown that clematis is effective at treating skin disorders, Drugs.com states that the species C. virginiana may have been used by native Americans to treat skin conditions like sores, cuts and itching. The early North American settlers may also have used it to treat venereal infections and in folk medicine, the leaves may have been used to treat cancers and tumors. Traditional Chinese medicine has investigated use of the roots of C. chinensis and several other species in a remedy known as weilingxian for its analgesic and anti-infective properties; however, the use of clematis may also cause skin irritation.
Inflammation
In Turkey, ground leaves have been applied to inflamed joints for pain relief. This remedy, though used for only 15 to 30 minutes, reportedly causes a wound to open on the skin to promote drainage of edema. Drugs.com states that the anti-inflammatory effects of clematis may be due to inhibition of the cyclooxygenase, COX for short, enzyme and other inflammatory chemicals; however, these effects are not well understood. Clematis should not be used or taken with other anti-inflammatory medications such as aspirin, ibuprofen or naproxen without the advice of a physician.
Adverse Reactions
Clematis species may contain a substance known as protanemonin, which may irritate and blister the skin. It may also result in inflammation and burning of the mouth and digestive tract. Kidneys may also be irritated with symptoms of painful, excessive and bloody urine. As it has a number of side effects and many species can be considered toxic, Clematis should not be taken except under the supervision of a qualified healthcare professional.
References
Bach Centre: Clematis
Drugs.com: Clematis
Article reviewed by Molly Solanki Last updated on: Jun 7, 2011
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Vitamins & Herbal Supplements Information & Side Effects
Jun 14, 2011 | By Carrie Cronkite
Vitamin and herbal supplements are designed to supplement your body with nutrients that may be lacking from your diet. Trying to use vitamin and herbal supplements to provide the bulk of your daily nutrients instead of eating healthy food can cause health problems. If you have a healthy diet, taking a high dose of vitamin or herbal supplements can have ill effects. Consult with your primary care provider before trying a new vitamin or herbal supplement.
Adverse Effects
Some vitamin and herbs can react with your prescribed medications producing undesirable effects. For instance, using the herb St. John's wort, commonly used to treat mild depression, can reduce the desired effects of your prescribed heart medications, antidepressants or oral contraceptives. If you are HIV positive, taking St. John's wort can reduce the effectiveness of some of your anti-viral medications.
Toxic Reactions
Vitamins A, D, E, K and F are considered fat-soluble vitamins. Fat-soluble vitamins only dissolve in fat and are stored in your liver. Too much of these types of vitamins can cause you to have a toxic reaction, because they are excreted from your body slowly. Some vitamins and herbs have similar properties compared to certain prescribed or over-the-counter medications and, if used co-jointly, can cause a possible toxic reaction.
Contraindications
The medication warfarin is a prescribed medication to keep your blood thin for a medical condition that you have. Certain vitamin and herbal supplements also thin your blood. Ginkgo biloba, vitamin E and A all have natural properties that thin your blood; combining these supplements with warfarin can have dangerous effects.
Overdose
Vitamin and herbal supplements are regulated by the FDA, but not as strictly as medications are. They fall under the category of food. Manufacturers of vitamin and mineral supplements do not have to receive approval from the FDA before marketing them. It is important to use caution before using any type of supplement. If a vitamin or herbal supplement contains more than 100 percent of the recommended daily allowance, it can be dangerous to your health. Certain medical conditions that compromise your liver or kidneys or if you take a thiazide diuretic, can put you at risk of overdosing on vitamin D. That is because of its oil-soluble properties. It is stored in your liver and excreted by your kidneys. If your kidneys are not functioning properly, poisoning can be the end result. Taking high doses of vitamin A can possible result in osteoporosis if you are older. Taking large amounts of vitamin A long-term can cause you to develop stomach discomfort, nausea, mental changes and fatigue.
References
MayoClinic.com: Herbal Supplements: What To Know Before You Buy
MayoClinic.com: What is Vitamin D Toxicity, and Should I Worry About It Since I Take Supplements?
National Institutes Of Health: What's In The Bottle? An Introduction To Dietary Supplements
FDA: Tips For The Savvy Supplement User: Making Informed Decisions And Evaluating Information
MedlinePlus: Herbs And Supplements
FAQs.org: Vitamins: Fat Soluble
Article reviewed by Helen Covington Last updated on: Jun 14, 2011
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Side Effects of Herb Supplements
Dec 12, 2010 | By Susan Ferrandino
Herbs represent a wide spectrum of supplements that are used for various reasons. As a result many side effects could occur. Supplements are not regulated by the Federal Drug Administration (FDA). The FDA is only made aware of a supplement coming on the market by the manufacturer and any claims made after use. Herbs are one category of supplements. A herb comes from a plant or a plant part such as leaves, roots, seeds or flowers. In one sense, botanical is synonymous with herbal. Before taking any herbal supplements, your health care provider needs to be consulted.
Laxative Effect
Popular herbal supplements such as aloe vera may cause diarrhea. Aloe vera in the oral form is called aloe latex. At one time, aloe latex was regulated by the FDA for its laxative effects. That is not longer the case since 2002 because it was supposedly taken off market shelves. However, the oral form of aloe vera supplements can be located in vitamin stores today. Taking milk thistle has spurred reports of gastrointestinal upset, which includes diarrhea, according to the National Institutes of Health.
Liver Damage
Kava is an herbal remedy used to help people fall asleep or reduce anxiety. It is also used to help combat menopausal symptoms such as hot flashes. The FDA has issued a warning about kava's link to potential liver damage. Black cohosh is a remedy for menopausal symptoms that can also cause liver problems. Women are advised to stop this supplement if they experience abdominal pain that is associated with liver problems.
Blood Coagulation
Garlic supplements, green tea and ginkgo biloba may increase the duration of time an episode of bleeding lasts in your body, according to the U.S. Department of Health and Human Services. This is especially true when you take an anticoagulant such as warfarin or aspirin, as these are supposed to thin your blood. Increased bleeding times mean you bruise and bleed easier because your blood is thinner. These are the therapeutic goals of particular prescribed medications but the blood is regulated with frequent lab tests. If a blood-thinning supplement were taken in addition to these medications, increased bleeding could result. If you experience any form of bleeding such as blood in the urine or in the gums, contact your health care provider.
References
National Institutes of Health: Dietary Supplements: Backgroung Information
National Institutes of Health: Aloe Vera
National Institutes of Health: Milk Thistle
National Institutes of Health: Kava
National Institutes of Health: Black Cohosh
U.S. Department of Health and Human Services: Blood Thinner Pills
Article reviewed by Knuckles Last updated on: Dec 12, 2010
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Hawthorn Berry Herb Side Effects
Apr 26, 2011 | By Traci Vandermark
Hawthorn berry is an herb that has been used for centuries for its health benefits. According to the University of Maryland Medical Center, it is a treatment for respiratory and circulatory disorders, as well as high blood pressure. Hawthorn is an herb that has few side effects, but because of its ability to effectively treat heart and blood pressure problems, the side effects that do occur are often related to those two systems.
Heart Side Effects
Because hawthorn is so effective in treating many heart issues, it can also cause side effects if taken by those who do not need it. While it is used to treat heart palpitations, one of the side effects can be an increase in heart palpitations. According to Memorial Sloan-Kettering Cancer Center, the palpitations, or increased heart rate, is often a sign of overdose. Other adverse reactions involving the heart are increased chest pain and fatigue during activity.
Digestive Side Effects
Reports of digestive trouble are occasionally reported with hawthorn use. A review on hawthorn berry in a 2006 issue of "Drug Safety" reports that nausea was one of the most commonly noted side effects, along with dizziness and intestinal hemorrhaging.
Medication Interaction Side Effects
The report in "Drug Safety" also states that the few negative side effects that are reported with hawthorn berry are often due to using the herb "unsupervised." This is especially the case if hawthorn is used while you are currently taking a prescription for treatment of heart problems or blood pressure. The UMMC reports that hawthorn berry can interfere with the effects of two medications in particular: digoxin and phenylephrine. Digoxin is used to treat irregular heartbeats, and hawthorn can interfere with, or adversely increase the effects of, this medication. Phynylephrine tightens blood vessels, and is found in many over-the-counter medications, and hawthorn expands blood vessels, which can render phynylephrine medications ineffective. Due to its action of relaxing blood vessels and increasing blood flow, if you are on medication to reduce blood pressure, using hawthorn can cause your blood pressure to go too low.
References
University of Maryland Medical Center: Hawthorn Berry
Memorial Sloan-Kettering Cancer Center: Hawthorn
Drug Safety: Hawthorn
Article reviewed by Elizabeth Ahders Last updated on: Apr 26, 2011
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Side Effects of 7 Days Herbal Slim
Jul 21, 2011 | By Sharon Thiel
Seven Days Herbal Slim is one of the weight loss supplements the U.S. Food and Drug Administration found to include prescription medications not listed on the label. This supplement, labeled an "herbal" supplement, contained sibutramine, a controlled medication used for obesity. Sibutramine works by affecting the areas of the brain that control appetite, to suppress your appetite and help you lose weight. The FDA was in the process of taking 7 Day Herbal Slim off the market as of December of 2008.
Side Effects
MedlinePlus lists the following side effects from taking sibutramine: back or menstrual pain, sleep difficulty, weakness, headaches, constipation, heartburn, flushing, nervousness, dry mouth and flu-like symptoms. Also, high doses can cause serious side effects like heart palpitations, tachycardia, high blood pressure and seizures.
Special Populations
Certain populations can develop side effects from sibutramine from a regular dosage amount. This includes people with narrow angle glaucoma, those affected by seizures or bleeding events and those with severe hepatic dysfunction. It is also a concern for people with coronary artery disease, arrhythmias, stroke, congestive heart failure and hypertension. Sibutramine can interfere with certain medications as well.
Considerations
MedlinePlus explains that sibutramine is no longer legally on the market in the United States. It was taken off after research showed that the substance created a higher incidence of heart attacks and strokes. However, as of July 2011, this product was still sold on the Internet, seemingly from Asia. It is not clear whether it still contains sibutramine, although the FDA explained that it was not previously listed in the label but found in the product.
FDA Recommendations
If you are currently taking 7 Days Herbal Slim, the FDA recommends that you stop taking it immediately and visit your health care provider. Also, if you have experienced side effects from it, report them to the FDA's MedWatch Adverse Event Reporting program. In the future, talk to your doctor before taking any weight loss supplements.
References
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France Pledges to Tighten Pharmaceutical Controls Following 'Mediator' Drug Scandal
(February 18th, 2011) A damning report has revealed chronic official failure to restrict the
use of Mediator, an anti-diabetic drug and slimming pill, despite known
lethal side-effects dating back over a decade. The drug is thought to
have killed at least 500 people in France and resulted in thousands of
hospitalisations over a 30-year period. Public outcry over the scandal
has prompted promises of an extensive reform of the French drug
regulatory system, reports Jeremy Garwood.
The report by the Inspection Generale des Affaires Sociales (IGAS, 15th January 2011, available in French only)
unequivocally condemned the “inexplicable tolerance” shown for the
drug, Mediator, by AFSSAPS, the French agency responsible for monitoring
the security of health products. It also directly accused Servier
Laboratories, the manufacturers of the drug, for its delayed response to
negative reports concerning the pharmacological effects of Mediator.
Serious questions have also been raised as to the
integrity of a succession of government ministers for Health and Social
Security - they were informed of the increasing evidence that this drug
was inappropriate for medical treatment, yet did nothing to remove it
from the list of medicines officially reimbursed by the French social
security system.
The current Health Minister, Xavier Bertrand, accused Servier Laboratories of direct responsibility.
A criminal investigation was launched in November, 2010. The IGAS
report presents evidence that Servier used dishonest marketing
strategies and paid officials to maintain its drug on the market for
years after its toxicity had first been reported.
The head of AFSSAPS was immediately forced to resign. Bertrand
said the drugs regulator had “failed in its mission” and ordered the
agency to accelerate checks on 76 other drugs currently on the watch list. The Health Minister said that the current system must change. Currently, AFSSAPS is dependent on the drugs companies themselves for over 80% of its finances. In the future, it will be publicly funded. He promised that drug
approval procedures would be tightened and that government
reimbursements for drugs of questionable efficacy would be reviewed.
Mediator was withdrawn from sale in France in November,
2009. By that time, it is estimated to have been responsible for the
deaths of between 500 and 2,000 people, the majority of whom took it as
an appetite suppressor. Bertrand confirmed that their families had a
strong claim for compensation.
Servier said it was investigating the
allegations made in the report. However, the group insisted that the
report had been prepared without any evidence taken from Servier itself.
The company said it was “stunned” by the findings that “do not appear to conform to reality”.
Benfluorex, the active ingredient of
Mediator, was first presented by Servier in 1970. As a fenfluramine, it
is in effect an amphetamine derivative. Mediator was sold from 1976
onwards as an anti-diabetic drug, reducing blood sugar levels in
overweight diabetics. However, apparently encouraged by Servier, doctors
began prescribing it as a slimming aid to patients worried about their
weight.
Mediator is an efficient appetite
suppressant, causing weight loss by reducing appetite and food
consumption. At least two million people in France took Mediator from
1976 to 2009. It was being prescribed to more than 300,000 patients a
year by 2009, representing some seven million boxes a year worth 300
million euros. Servier dominated the market for appetite suppressants in
the 1990s with Mediator and a related drug, Isomeride, whose active
ingredient is dexfenfluramine.
In 1997, dexfenfluramine was banned in the US, where it had been found responsible for cardiac valvular disease and pulmonary
hypertension due to the toxic effects of its metabolite,
norfenfluramine. In 1997, it was also withdrawn in France. At that time,
a French investigation also reported that Mediator produced the same
toxic metabolite. It also found that the drug was being widely
misprescribed as an appetite suppressant, even though it was only
officially approved for use as an anti-diabetic.
Despite this negative report and a
series of others, both in France and elsewhere, French authorities did
nothing to restrict the drug’s use. By 2006, Mediator was banned
worldwide except for in Portugal, Cyprus and France. Indeed, in October
2009, AFSSAPS even approved the marketing of two new generic
preparations of Mediator, just a month before it was banned.
Medical authorities finally intervened because of a
public campaign by Irene Frachon, a medical doctor from Brittany who,
having found cardiac valve disease in 11 patients taking Mediator,
subsequently uncovered the scandal.
Jacques Servier, the 88 year old
founder and chairman of Servier Laboratories, has continued to deny any
wrongdoing, making such controversial statements as: “500 is a very nice
marketing number but it’s probably closer to three deaths.” On the 7th
February, police seized documents from Servier’s headquarters in
Neuilly-sur-Seine as part of the legal investigation into Mediator.
Meanwhile, French President Sarkozy asked medical
Professors, Bernard Debré and Philippe Even, to present recommendations
for urgent reform. The main points of the Debré-Even report were
released at the end of January:
First, AFSSAPS did nothing to restrict Mediator’s use,
despite ample evidence of toxicity and misuse. Clearly, it can no longer
continue to be financed by the pharmaceutical industry that it is
supposed to be controlling. From now on, it must be directly financed by
the French government.
The lack of impartiality of French
medical professionals has also been exposed in this case – for example,
two doctors paid by Servier were advisors to the Health Ministry, in
2006, when it decided to continue with Mediator. They now want all commercial links between medical professors and the pharmaceutical companies to be made public.
They also recommend that independent ‘personalities’ be
appointed to control the entire pharmaceutical drug industry in France –
at least two scientific directors from Servier had a clear conflict of
interest when they occupied key posts in the society responsible for
monitoring correct use of therapeutic drugs.
Finally, they call for a better diffusion of new information about
medicines with, for example, a re-education of medical doctors every
five years and public access to updates over the internet.========================
Herbal Viagra
Advertisements for the so-called natural alternatives to Viagra are everywhere, promising to spice up your sex life, News 2's Paul Moniz reports.
The makers of "Herbal V" say it's hope in a bottle, the ultra pleasure delivery system.
The manufacturers of "Cobra" claim their product improves stamina, performance and virility.
The audience these ads targets is huge: experts say that more than 30 million men suffer from erectile dysfunction, many of whom are embarrassed to seek help.
That's one reason why the supplements are so popular: unlike Viagra, you don't need a prescription. But a $10-per-pill price tag and side effects such as dizziness, flushing and more than 500 deaths to date make many patients reluctant to take it.
That's why herbals are so popular.
However, one consumer watchdog group is sounding an alarm.
"They're greatly exaggerating the benefits of these products," says David Schardt, who is with the not-for profit Center for Science in the Public Interest.
His group recently examined the nine main ingredients in herbal potency supplements the scientific support behind them. Overall, the results were not encouraging: there is very little research behind these supplements.
Still, urologist Dr. Robert Salant, who works at NYU Medical Center, says many patients are undeterred.
"There's a belief that these supplements are safer than prescribed medications," he says.
But herbal supplements are not regulated by the Food and Drug Administration, so they may not necessarily be less risky.
One supplement, yohimbe, which is a tree bark, is also available as a prescription under the name, "Yohimbine." It has been cited by the FDA for causing kidney failure, seizures and even death.
Few of the supplements that have been tested on humans are supported by double-blind placebo studies, which are hailed as the gold standard comparing the supplements' results with those of a sugar pill.
For example, the shrub extract, damiana, found in "Cobra," might help…if you're a rat: the substance has not been tested on humans; neither has the vegetable root, maca.
The CSPI Review suggests the supplement, "Argin-Max" may offer some benefit. It's a combination of the amino acid l-arginine, ginko biloba ginseng and a blend of vitamins.
A yet-to-be-published placebo study of 50 men showed 84 percent reporting improved erections. Eighty percent were happier with their overall sex life.
Dr. Salant calls the results encouraging but he remains skeptical.
"I would just caution everyone looking at the data that this is a very short term study with very small numbers," he says.
Even if herbal supplements do yield good results, they may mask a serious medical condition, such as diabetes, multiple sclerosis or thyroid imbalance, which may be causing erectile dysfunction.
It is always best to consult a physician rather than self-prescribe and diagnose.
=========================
Herbal Medicine
Herbal supplements have exploded into a $5 billion industry but remain unregulated by the Food and Drug Administration. While herbs are regarded as a safe and gentler alternative to conventional drugs they can cause problems when mixed with standard medication. On Tuesday's The Early Show Health Correspondent Dr. Emily Senay gave examples of dangerous herb-drug interactions and informed viewers how to check for more information.
Herbal supplements are extremely popular. One recent poll suggested 60 million Americans are taking some form of herbal supplement and are spending an average of $54 a year on herbs.
Compared to prescription and over-the-counter drugs, herbs are seen as safe products. Between 1993-98 the FDA received 2,600 reports of problems and 101 deaths linked to herbal supplements. Meanwhile every year in the United States 100,000 people die from problems associated with traditional drugs.
However, researchers are sounding an alarm over dangerous herb-drug interactions. Herbs have medicinal properties that can trigger serious reactions when combined with conventional pharmaceuticals.
========================
Herbal Medicine Taken on Faith?
Many People Don't Consult Scientific Guidelines on Herbal Supplements
By
Miranda Hitti WebMD Health News Reviewed by
Louise Chang, MD
"Physicians, pharmacists, and other health professionals should proactively educate consumers and advocate for public health policies that would disseminate evidence-based information regarding the appropriate use of herbs," says researcher Aditya Bardia, MD, in a University of Iowa news release.
Bardia and colleagues reviewed data from a 2002 national health survey of more than 30,000 U.S. adults.
In the survey, more than 3,300 adults said they had taken herbs to treat a specific health condition.
The researchers focused on 609 people who reported treating a specific health condition with any of the following 10 herbal supplements: echinacea, ginseng, garlic, St. John's Wort, soy, or kava kava.
Bardia's team checked to see if there was scientific evidence supporting the use of those herbal supplements for the participants' health conditions.
Overall, about 55% of the participants used herbal supplements backed by scientific evidence for their condition.
However, the percentage of participants using herbal supplements in accordance with scientific evidence ranged from 68% for echinacea to 3% for ginseng.
Apart from echinacea and ginseng, about one-third of the participants used herbal supplements based on scientific evidence, the study shows.
Part of the problem may be that many patients and doctors don't talk about herbal supplements. That should change, note Bardia and colleagues.
Their report appears in the May edition of the journal Mayo Clinic Proceedings.
==========================
Natural does not equal safe: “You should remove that wort” edition
A study this month ($) in Pharmacoepidemiology and Drug Safety (just rolls off the tongue doesn’t it?), looked at poison control data during 2001 for two herbal supplements: St. John’s wort and Echinacea.
There were 356 contacts for SJW and 406 contacts for Echinacea. That’s not what interests me; we know the compounds are bioactive and have toxicities associated with their use (See here for the adverse effects seen from these contacts). SJW is even implicated in suicidal and aggressive thoughts (Nanayakkara et al. 2004. Ned Tijdschr Geneeskd. 149; 1347-1349) and interferes with many prescription drugs, many times limiting the amount of active drug that your body is exposed to. What interests me here is that the percentage of young people experiencing adverse effects was lower than the adults (For Echinacea: 3.4 vs 28.9%; For SJW 14.4 vs 46.4%). Possibilities: 1) Since children’s exposures were largely accidental, they took very little compared to the intentional adult exposure. 2) Children who ingest any supplement are more likely to be reported whether they have symptoms or not while adults are more likely to reported only if they take too much or experience adverse effects. 3) Children are less sensitive to Echinacea and SJW (not likely base on current evidence).It would be useful to run this down to get some firm numbers on adverse reactions of children to herbal supplements (especially those which contain a lot of caffeine like guarana). The poison control center data is well known to underestimate exposure and toxicity due to severe underreporting (even for poisonings leading to death). Additionally, only contacts which Echinacea and SJW were the only associated products were included to keep the analysis clean. The bigger point, however, is that poison control centers get contacts every year (by the numbers, at least a couple a week) about harmful effects of children or adults taking Echinacea or SJW.
So, I know it’s legal and natural* but it’s not safe; that goes double if you’ve got kids in the house. Oh, and shouldn’t GNC et al. put their snake oil into child safe bottles? Not that they really care about anyone’s health anyway, but it’s nice to dream.
*I don’t consider it natural as it’s extracted and processed. It’s like saying digoxin is natural becuase of foxglove; or gasoline because of crude oil.
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The dangers of smoking shisha
SHISHA is herbal tobacco which is smoked through a water pipe, also known as a ‘hookah’ pipe.
An average smoking session will see 10 milligrams of fruit tobacco smoked for 30 minutes.
It is a shared experience where one or more pipes can stem from the shisha pipe.
Shisha bars are popular with Indian, Bangladeshi and Pakistani communities who see it as a social hub and central to their culture.
It is mainly smoked after dinner with guests or at a cafe. The tobacco flavours come from across the world and can range from melon to cappuccino.
Flavoured tobacco or herbal fruit pulp fills the clay pot, is covered with pin-pricked foil, then heated by coal Shisha is often seen as a safer, more acceptable form of smoking.
But there are concerns that it is far more dangerous than cigarettes. Research by the Department of Health and the Tobacco Control Collaborating Centre found dangerous levels of carbon monoxide with shisha.
According to the centre, the carbon monoxide levels from shisha can be up to 450 times higher than filtered cigarettes.
High levels of carbon monoxide can lead to brain damage and unconsciousness.
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Herbal Amphetamines Linked to Higher Risk of Stroke and Death
Herbal amphetamines are a class of drugs that are currently
unregulated in most parts of the world. They create a high much like
crystal meth and cocaine, but because they are plants or plant-based,
many users believe that they are safer to use. Unfortunately, learning
just how dangerous these herbal drugs can be is a deadly lesson for
many. A new study published in Circulation: Journal of the American Heart Association confirms that use of herbal amphetamines can be fatal in certain circumstances.
When addiction becomes an issue, risk of health problems worsen. Users often suffer from malnutrition due to decreased appetite, which in turn leads to a multitude of problems, including kidney failure and liver failure.
If stimulant abuse of any kind is a problem for you, help is available. Residential and outpatient addiction treatment programs can help you learn how to stop abusing the drug and learn new ways to deal with stressors in your life. Call now to learn more about how available programs can help you avoid the health effects of continued drug abuse.
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Things to Consider Before Using Herbs and Other Dietary Supplements
Khat
Khat is a plant-based herbal amphetamine and the subject of the recent study. Users chew the drugs to experience stimulant effects similar to those experienced by users of cocaine and amphetamines, a practice common among certain populations in the Arabian Peninsula and East Africa where the plant is most often found. The study discovered that this use of the drug not only contributed to the development of heart disease but to stroke and death in patients already living with heart disease.Effects and Usage
Effects of the drug include a euphoric high, weight loss, restlessness and increased rates of activity – much like cocaine and crystal meth. Americans, especially teens, are using this drug and others like it in higher and higher numbers, and authorities are concerned about the increase of accident and health problems related to use and abuse of the drug. Users can purchase the drug online and in some head shops since there is little in the way of regulation of the drug in the United States. The rate of heart disease and death due to stroke increased significantly with time spent in active addiction.Treating Stimulant Abuse and Addiction
Whether the drug of choice is khat, crystal meth, amphetamine or cocaine, stimulant drugs have been proven time and again to contribute to serious heart problems, stroke, seizures and death. When the drug is mixed with alcohol, the rate of overdose skyrockets, especially among young people who like to abuse stimulants so that they can drink longer.When addiction becomes an issue, risk of health problems worsen. Users often suffer from malnutrition due to decreased appetite, which in turn leads to a multitude of problems, including kidney failure and liver failure.
If stimulant abuse of any kind is a problem for you, help is available. Residential and outpatient addiction treatment programs can help you learn how to stop abusing the drug and learn new ways to deal with stressors in your life. Call now to learn more about how available programs can help you avoid the health effects of continued drug abuse.
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Things to Consider Before Using Herbs and Other Dietary Supplements
Phoenix Montoya @1124montoya Ranked #5 in Wellness FOLLOW
While some people regard herbs and
dietary supplements as useless, there are also individuals that claim
these beneficial and safer than the actual medications. The good news,
herbs and food supplements could actually work; the bad news, they can
be harmful too.
Oregano is a notorious herbal plant in the Philippines. While visiting in Bicol, I learned a queer practice with this herb. I was instructed to steam two to three leaves of it, and then squeeze the liquid of these leaves on a tablespoon. I was about to take the cure but the elderly who recommended the oregano herb, advised me to go out of the house to let the afternoon moist get into the oregano extract.
While the first two steps made sense, the last one had been puzzling. The herb did work for me. And why wouldn’t it? Since the earlier times, oregano had been known to be effective for cough.
Too much of a good thing
Most people say that natural products have no side effects. This is myth, its either they are using too little of it or the supplement or herb is still new and hasn’t been used for a longer period of time. The thing is: one problem in using herbs and other supplements is that some individual do not know how to use these.
Taking a natural remedy or supplement is also like using the synthetic drug. You must also consider the strength and the dosage regimen. While an inadequate dose may not provide a desired result, an over dose can be harmful too. If you would want to take herbal cure, seek advice to experts who have already been successful in using the remedy. For supplements, follow the instructions on the label. It is also important to talk to your doctors before engaging to these cures. Herbal medicines and supplements may cause problems with your other medications.
Drug interactions
If you are taking maintenance drugs like antihypertensive or oral hypoglycemic types for your high blood pressure or diabetes respectively, it is important that you check the herb or the supplement you intend to use. Ginkgo biloba for instance, is said to be beneficial for the elderly for it can help treat age-associated memory impairment including Alzheimer’s. However, if an individual is taking a diuretic or other blood pressure control medicine, gingko biloba may hinder the effect of these drugs.
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Ginkgo biloba won’t also work with aspirin and other blood thinners like clopidogrel, ticlopidine, warfarin, heparin etc. This herb contains some constituents that affect blood clotting therefore, can potentiate the effect of the anti-coagulant drugs causing uncontrolled bleeding or haemorrhage.
Not all natural products are safe
The belief, ‘Natural, dietary products cannot hurt’ is another myth. Consider hemlock, cyanide or cocaine- these are natural products that originated from plant. Marijuana is usually used in its unadulterated form, would you consider this one safe?
A 2003 issue of The New England Journal of Medicine reported a study that checked more than 100 websites that are selling 115 herbal products which are suspected to contain aristolochic acid- an ingredient that has been found to cause cancer and kidney failure. The mentioned on-line products were Cold Away, Mothers Earth cough syrup, Cramp Relief, PM- Ease and Wild Indian hemp syrup. Neither the websites nor the manufactures of these products told the consumers what they need to know.
And why would they? The side effects were mere suspicions and naturally, manufacturers or dealers won’t reveal a flaw of their product. Remember that herbs and dietary supplements are classified as food supplements not drugs. These products are not inspected thoroughly by the FDA. No clinical trials or tests have been done unlike the prescription or the over-the-counterdrugs. And sadly, the safety and the effectiveness of these food supplements do not have to be documented.
The anecdotal evidence
Unlike drug products that are tested for a long period of time, health products may not have enough clinical proofs. However, they do have anecdotal evidences. Food supplement manufacturers usually make use of these for promotions. Anecdotal evidence refers to success stories of people who have found relief in using herbs or dietary supplements. While anecdotal evidences may be found in Medias like in magazines, television or posted in websites, these may come directly from the mouth of the user or as a recommendation of a trusted physician.
In the English dictionary, anecdotal means unreliable. The individual who has been successful with a food supplement was not observed by anyone taking it or how he has taken it. For one thing, what if there are some factors that could have affected the person’s condition while taking the food supplement?
Anecdotal evidences may be undependable but if 75 out of 100 people have the same confirmation then there’s a chance!
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Herbs and other dietary supplements do work. We just have to learn to use them properly and of course bear in mind the dangers. Taking herbal or dietary supplement is more risky than the actual drugs. People fear prescription or over-the-counter drugs because of the known side-effects but bear in mind that most food supplements have no known adverse reactions because they lack clinical testing.
© Phoenix Montoya @ January 13, 2011
References:
Smart Medicine by Peter Weaver
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On Managing Drug Side-Effects
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