Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids.
BACKGROUND
Dietary supplements that contain ephedra alkaloids (sometimes called ma huang) are widely promoted and used in the United States as a means of losing weight and increasing energy. In the light of recently reported adverse events related to use of these products, the Food and Drug Administration (FDA) has proposed limits on the dose and duration of use of such supplements. The FDA requested an independent review of reports of adverse events related to the use of supplements that contained ephedra alkaloids to assess causation and to estimate the level of risk the use of these supplements poses to consumers.


METHODS
We reviewed 140 reports of adverse events related to the use of dietary supplements containing ephedra alkaloids that were submitted to the FDA between June 1, 1997, and March 31, 1999. A standardized rating system for assessing causation was applied to each adverse event.


RESULTS
Thirty-one percent of cases were considered to be definitely or probably related to the use of supplements containing ephedra alkaloids, and 31 percent were deemed to be possibly related. Among the adverse events that were deemed definitely, probably, or possibly related to the use of supplements containing ephedra alkaloids, 47 percent involved cardiovascular symptoms and 18 percent involved the central nervous system. Hypertension was the single most frequent adverse effect (17 reports), followed by palpitations, tachycardia, or both (13); stroke (10); and seizures (7). Ten events resulted in death, and 13 events produced permanent disability, representing 26 percent of the definite, probable, and possible cases.


CONCLUSIONS
The use of dietary supplements that contain ephedra alkaloids may pose a health risk to some persons. These findings indicate the need for a better understanding of individual susceptibility to the adverse effects of such dietary supplements.
Haller
C A
CA
Department of Medicine, University of California, San Francisco, and the California Poison Control System,  94143-1220, USA.
Benowitz
N L
NL
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D001145:Arrhythmias, Cardiac / Q000139:chemically induced; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D019587:Dietary Supplements / Q000009:adverse effects*; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*; D029790:Ephedra sinica; D004809:Ephedrine / Q000009:adverse effects*; D017809:Fatal Outcome; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D020300:Intracranial Hemorrhages / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D028321:Plant Preparations; D012640:Seizures / Q000139:chemically induced; D014481:United States; D014486:United States Food and Drug Administration; D029789:Ephedra
D004365:Drugs, Chinese Herbal; D028321:Plant Preparations; C099950:Ephedrae herba; D004809:Ephedrine