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Report on dietary supplements containing ephedra makes urgent call for research to develop dose guidelines, safety warnings

A study undertaken for the Food and Drug Administration to assess the safety of popular dietary supplements containing ephedra concludes that these products can pose severe health risks and even kill some people, prompting an urgent need to pinpoint those at greatest risk and establish safe daily doses for the supplements. Scientists at the University of California, San Francisco who conducted the study also say ephedra-containing products should be more uniformly and explicitly labeled.

The analysis will appear in the December 21 issue of The New England Journal of Medicine. It has been posted early on the journal's web site due to its health implications.

The paper draws on a study the UCSF team prepared for the FDA, assessing 140 reports the agency received on adverse effects from ephedrine-containing supplements. The full report was published in the Federal Register earlier this year.

Of the 140 reports the FDA received concerning adverse effects analyzed, 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 these 43, three died, seven suffered permanent injury and four more required on-going medical treatment, the report shows.

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

When a second group was included in the analysis - those whose physical symptoms were "possibly" related to ephedrine products - the number of deaths rose to ten out of 87 people, and permanent disabilities rose to 13 out of the 87.

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 urge the FDA to move q
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Contact: Wallace Ravven
wravven@pubaff.ucsf.edu
415-476-2557
University of California - San Francisco
6-Nov-2000


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