The severity of toxic reactions to ephedra: comparisons to other botanical products and national trends from 1993-2002.
OBJECTIVE
Ephedra is a botanical product widely used to enhance alertness, as a weight loss aide, and as a decongestant. Its reported adverse effects led the Food and Drug Administration (FDA) to ban ephedra-containing products in the United States in 2004. This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products.


METHODS
The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993-2002. Cases listing both a botanical product and any other drugs or chemicals were excluded a priori. Ten-year hazard rates (moderate outcomes + major outcomes + deaths per 1000 exposures) were used to compare botanical product categories.


RESULTS
There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4306 (19.9%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures. The rate ratios for multibotanical products with ephedra (RR 1.33; 95% C.I. 1.27-1.40) and for single-ingredient ephedra products (RR 1.25; 95% C.I. 1.11-1.40) were both two to six times higher than those of other common botanical products. Yohimbe-containing products had the highest hazard score (417) and rate ratio (2.08; 95% C.I. 1.59-2.80).


CONCLUSIONS
Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center-reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products. These data support recommendations by policymakers that the sale of ephedra should be prohibited to protect consumers. Our data suggest that the botanical product, yohimbe, may also be associated with unacceptably high risks of toxicity and should receive close scrutiny from health policymakers.
Woolf
Alan D
AD
Division of General Pediatrics, Children's Hospital, Boston, Massachusetts 02115, USA. alan.woolf@childrens.harvard.edu
Watson
William A
WA
Smolinske
Susan
S
Litovitz
Toby
T
D003625:Data Collection / Q000379:methods; D016208:Databases, Factual; D004638:Emergency Treatment / Q000401:mortality / Q000706:statistics & numerical data / Q000639:trends*; D029790:Ephedra sinica / Q000737:chemistry / Q000633:toxicity*; D006801:Humans; D008517:Phytotherapy / Q000009:adverse effects; D028321:Plant Preparations / Q000737:chemistry / Q000633:toxicity*; D011039:Poison Control Centers / Q000458:organization & administration / Q000706:statistics & numerical data / Q000639:trends; D018570:Risk Assessment / Q000379:methods / Q000639:trends; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D028321:Plant Preparations