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Old 04-17-2003, 05:51 AM   #1  
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Default NCCAM Consumer Advisory on Ephedra


Revised February 28, 2003

Dietary supplements containing ephedra, which have been in the news recently because of the deaths of well-known athletes, may cause rare but serious health consequences. The U.S. Department of Health and Human Services (HHS) announced on Friday, February 28, 2003, a series of actions designed to protect the public from the risks of dietary supplements containing ephedra. HHS and its component agencies all caution the public that the use of ephedra poses health risks, especially when used for strenuous exercise and when used with other stimulants such as caffeine.

What is ephedra?
Herbal products containing ephedra (also known as herbal ephedrine alkaloids) are marketed in the United States as dietary supplements that claim to promote weight loss, increase energy, and enhance athletic performance. Ephedrine alkaloids, including the chemical known as ephedrine, are amphetamine-like compounds that potentially have powerful stimulant effects on the nervous system and heart. These alkaloids are found naturally in a number of plants, including the ephedra species of herbs (also known by its traditional Chinese medicine name--ma huang or Chinese Ephedra, or epitonin), but they can also be manufactured in the laboratory.

Like an amphetamine, ephedra stimulates the central nervous system, increasing blood pressure and heart rate, decreasing appetite, and making the user feel energetic. In synthetic form, ephedrine is regulated as a drug and is used as a decongestant for the short-term treatment of asthma, bronchitis, and allergic reactions by opening the air passages in the lungs.

What are ephedra's side effects and risks?
Although dietary supplements containing ephedra are widely used, many adverse event (serious reactions and problems) reports have been received by the U.S. Food and Drug Administration (FDA). These reports have raised questions regarding ephedra's overall safety. Serious side effects reported in ephedra users include nausea and vomiting, psychiatric disturbances such as agitation and anxiety, high blood pressure, irregular heartbeat, and more rarely seizures, heart attack, stroke, and even death. The International Olympic Committee, the National Football League, the National Collegiate Athletic Association, minor league baseball, and the U.S. Armed Forces have all banned the use of ephedra.

Scientific review of ephedra
NCCAM and the National Institutes of Health (NIH) Office of Dietary Supplements sponsored, through the Agency for Healthcare Research and Quality, a systematic review of the existing scientific literature on ephedra efficacy and safety in weight loss and athletic performance enhancement. The report, conducted by the RAND Corporation, is available at nccam.nih.gov/health/alerts/ephedra/rand.pdf. The review was conducted to assist NIH in developing an appropriate research agenda, to identify gaps in knowledge, and to suggest study designs that would yield more definitive answers regarding its safety.

FDA seeking public comment
The FDA is reviewing whether ephedra-containing products should be on the market. Dietary supplements are not regulated the same way as drugs are. The Dietary Supplement Health and Education Act (DSHEA) requires proof of harm--a higher standard than used in prescription drug development--before a supplement like ephedra can be banned from the market. NIH-sponsored research like the recent RAND report provides the evidence on which decisions about the safety and effectiveness of products can be assessed. On February 28, 2003, the FDA announced that it is asking for public comment on whether, in light of the RAND report and other newly reported research findings, ephedra poses an unreasonable risk as currently marketed under DSHEA.

NCCAM ephedra research
In addition to supporting the RAND study with the NIH Office of Dietary Supplements and a recent study of reports to poison control centers of reactions to ephedra and other herbal products, NCCAM is funding two laboratory studies of ephedra to better understand the mechanism of action and chemical properties of this herb.

Pharmacology of Combined Ephedrine/Caffeine Supplements, University of California, San Francisco
Effects of Ephedra on Human Adrenoceptor Subtypes, University of Mississippi
The National Advisory Council on Complementary and Alternative Medicine will review the RAND report and additional research findings and discuss what further research studies concerning the safety or effectiveness of ephedra might be warranted. The Advisory Council will meet by conference call on March 17, 2003.

At present, there is no evidence that ephedra products enhance athletic performance and only preliminary evidence that ephedra promotes small amounts of weight loss for a few months. There is evidence that ephedra is associated with an increased risk of side effects, possibly even fatal ones.

NCCAM will be considering further research on ephedra, but in the meantime, people should be concerned about the significant risks it poses while offering limited benefits. While respecting the traditional uses of herbal medicines, their long history, and their potential health benefits, NCCAM believes that ephedra poses unique public health challenges that warrant the public's attention.

Advice to Consumers
Safety should be the primary concern for all users of ephedra.

Consumers under the age of 18 or pregnant or nursing women should not use ephedra products.

Adults should consult a health care provider before using ephedra products if they have a history of high blood pressure, heart or thyroid disease, a seizure disorder, depression, diabetes, difficulty urinating, prostate enlargement, glaucoma, or are using any prescription drug.

Consumers should consult with a physician prior to using dietary supplements containing ephedra if they are also using a monoamine oxidase inhibitor (MAO inhibitors are drugs used in the treatment of selected atypical depressions) or any allergy, asthma, or cold medications containing ephedrine, pseudoephedrine, or phenylpropanolamine.

Consumers should discontinue use of ephedra and consult a physician if any of the following symptoms are experienced: rapid or irregular heartbeat, chest pain, severe headache, shortness of breath, dizziness, loss of consciousness, sleeplessness, or nausea.
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