Health Professionals

An Examination of Whether Dietary Supplements Containing Ephedrine Alkaloids Are Associated with Significant Abuse or Dependence

Issue: Whether dietary supplements containing ephedrine alkaloids are associated with significant abuse or dependence.

Findings: The Food and Drug Administration's (FDA's) adverse event reports (AERs) and other available data routinely used to evaluate drug abuse do not show that dietary supplements containing ephedrine alkaloids are associated with significant abuse or dependence.

Methodology: Dr. Edgar Adams, an Ephedra Education Council (EEC) Expert Panel member, reviewed data from a variety of sources in order to determine whether dietary supplements containing ephedrine alkaloids are associated with significant abuse or dependence. Dr. Adams reviewed the adverse event reports submitted to FDA that were possibly related to abuse or dependence, and he reviewed data from the Drug Abuse Warning Network (DAWN) to determine the incidence of reports related to products containing either synthetic ephedrine or ephedrine alkaloids from herbal extracts of ephedra. He also reviewed the data that the Texas Department of Health (TDH) provided to FDA in response to FDA's 1997 proposed rule to regulate the amount of ephedrine alkaloids in dietary supplements.

Analysis ‚ No Significant Abuse or Dependence: Dr. Adams found that none of the 276 AERs that FDA released on April 3, 2000 met the criteria for "dependence," as provided in the American Psychiatric Association's (DSM-IVô) Diagnostic and Statistical Manual (4th ed.). Only one AER may have met the criteria for "abuse," but the information needed to make an accurate assessment was lacking from this report.

Dr. Adams' review of the DAWN data indicate that, over the last few years, there has been a declining trend in the number of reports on ephedrine. In fact, the number of ephedrine-related episodes reported in 1998 were less than half of those reported in 1996. Of the 1996 reports, more than half are related to suicide attempts, which is an occurrence that is unrelated to abuse or dependence.

Dr. Adams has also reviewed information from FDA's database of over 800 AERs, including information contained in TDH's files. His review uncovered a relatively small number of possible but unconfirmed abuse reports. Considering the millions of consumers who annually use ephedrine products, the only meaningful conclusion Dr.ÝAdams could reach from both the AERs and the DAWN data is that there is no cause for concern over ephedrine abuse or dependence, and if there is any abuse, it is minimal.

Conclusion: There is no significant abuse or dependence associated with the consumption of dietary supplements containing ephedrine alkaloids.

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