Psychiatric effects of ephedra use: an analysis of Food and Drug Administration reports of adverse events.
OBJECTIVE
As part of a synthesis of evidence regarding the efficacy and safety of ephedra, the authors describe data on psychiatric adverse events from reports submitted to the Food and Drug Administration (FDA).


METHODS
The authors reviewed all 1,820 adverse event reports related to dietary supplements containing herbal ephedra from FDA MedWatch files as of Sept. 30, 2001. Fifty-seven serious psychiatric events were reported.


RESULTS
The most commonly reported events were psychosis, severe depression, mania or agitation, hallucinations, sleep disturbance, and suicidal ideation. Ten events involved physical harm to self or others; five events resulted in legal action due to criminal behavior. Twenty-six events resulted in hospitalization, at least six of which were involuntary. Of importance, two-thirds of all cases involved patients with preexisting psychiatric conditions and /or use of other medications or illicit substances.


CONCLUSIONS
Clinicians should be aware that serious psychiatric symptoms could be associated with ephedra use.
Maglione
Margaret
M
RAND, Santa Monica, CA 90407, USA. maglione@rand.org
Miotto
Karen
K
Iguchi
Martin
M
Jungvig
Lara
L
Morton
Sally C
SC
Shekelle
Paul G
PG
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D019587:Dietary Supplements / Q000009:adverse effects; D029789:Ephedra / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced* / Q000453:epidemiology; D008875:Middle Aged; D028321:Plant Preparations / Q000009:adverse effects* / Q000627:therapeutic use; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data*
D028321:Plant Preparations