PRO & CON.

Should the FDA continue current dose restrictions for ephedrine alkaloids?

Dr. Donald D. Hensrud is director of the Executive Health Program at the Mayo Clinic, Rochester, Minn.

YES

The Food and Drug Administration received 140 reports of adverse events associated with the use of dietary supplements containing ephedrine alkaloids during the period June 1997 through the end of March 1998. These reports were reviewed by two clinical pharmacologists at the University of California, San Francisco. Last December, they reported that 48 of the events, which occurred in 43 people, were definitely or probably related to the use of supplements containing ephedrine alkaloids (N. Engl. J. Med. 343[25]:1833-38, 2000).

Many clinically significant, life-threatening adverse events were included among these 43 cases: 5 people who had a cardiac arrest or sudden death; 2 with myocardial infarctions; 3 with arrhythmias; 4 with strokes; 1 with seizures; and 8 people with palpitations, tachycardia, or both. Three of these cases resulted in deaths, seven led to permanent impairments, and four people require ongoing medical treatment. The remaining 29 cases had full recovery.

Many of those with serious adverse events were young and otherwise healthy.

The authors of this analysis also noted that, based on statistics gathered by manufacturers of ephedrine-containing dietary supplements, about 12 million Americans are estimated to have used such supplements during 1999. Although the number of reported adverse events was small relative to the estimated number of users, the FDA must weigh the risks for the entire population.