Report: Ephedra supplements can be dangerous

ATLANTA, Georgia (CNN) -- A study undertaken for the Food and Drug Administration concludes that popular dietary supplements containing ephedra products can pose severe health risks and even kill in some cases.

Scientists at the University of California, San Francisco, also said ephedra-containing products should be more uniformly and explicitly labeled. They said there is an urgent need to pinpoint those at greatest risk and to establish safe daily doses for the supplements.

The analysis will appear in the December 21 issue of The New England Journal of Medicine, but it was posted early on the journal's Internet site due to its health implications.

The paper draws on a study the UCSF team prepared assessing 140 reports of adverse effects from ephedrine-containing supplements.

Of the 140 reports the FDA received concerning adverse effects, the researchers found that just under a third (31 percent), or 43 of the people "definitely" or "probably" suffered an adverse effect from ephedrine in a dietary supplement. Of the 43, three died, seven suffered permanent injury and four more required ongoing medical treatment, the report shows.

Serious effects among those people included five cardiac arrests -- two fatal and three resulting in permanent brain damage and disability -- four strokes and 10 cases of hypertension.

The researchers call for large-scale, controlled studies to quantify the dangers of ephedrine-containing products and to identify who is vulnerable to the serious side effects -- steps needed to determine a maximum daily safe dose.

The UCSF scientists also urged the FDA to move quickly to impose more uniform, mandatory labeling of contents and quantities. In addition, they said, the claimed benefits of these products are questionable and unproven compared with potentially severe risks.

Ephedrine-containing supplements are popular products in the United States, used by about 12 million people, with some three billion "servings" sold last year, according to industry statistics. They are stimulants, used for short-term energy boosts to enhance athletic performance and endurance, to help people exercise longer, feel more alert, and to dampen appetite.

Most of the stimulating supplements are derived from the herbal plant ma huang, and often also contain caffeine derived from guarana.

The researchers said that since ephedrine-containing supplements are stimulants, the people who should avoid them are those who have kidney disease, those with preexisting heart disease, high blood pressure, overactive thyroid, or psychiatric disorders, and those with autonomic insufficiency -- abnormalities in the nerves controlling their cardiovascular system -- and those with histories of seizures and diabetes.

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FDA/CFSAN Dietary Supplements: Overview
Ephedra Education Council
The Ephedrine and Ephedra Injury Page
New England Journal of Medicine On-line -- Home Page

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