Addressing the potential risks associated with ephedra use: a review of recent efforts.
The appropriate amount of oversight for dietary supplements has been a subject of debate for over a decade. This debate has come to a head recently with herbal ephedra, which may be associated with adverse events including heart attack, stroke, seizure, and death. This article reviews and puts into context recent findings on the safety concerns related to ephedra, based primarily on adverse event reports. It presents the response from industry and the FDA in light of this evidence, and describes additional steps taken by other groups who believe that more restrictive action is required. The article concludes by observing the lack of explicit, shared criteria for determining whether a supplement is unsafe, and pointing out ways in which the experience with ephedra can be used constructively to address that problem.
Schulman
Sara
S
U.S. Department of Health and Human Services, Office of Inspector General, Boston, MA 02203, USA. sschulman@oig.hhs.gov
D016907:Adverse Drug Reaction Reporting Systems; D019440:Anti-Obesity Agents; D001249:Asthma / Q000188:drug therapy; D002986:Clinical Trials as Topic; D000075202:Contraindications; D019587:Dietary Supplements / Q000009:adverse effects*; D004300:Doping in Sports; D017277:Drug Approval; D004348:Drug Labeling; D029789:Ephedra / Q000009:adverse effects*; D006801:Humans; D008517:Phytotherapy / Q000009:adverse effects*; D018570:Risk Assessment; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D019440:Anti-Obesity Agents