Adverse Effects and Toxicity 81 General Overview

Two journal articles analyzing adverse event reporters (AERs) have been published in the peer-reviewed literature, and both reports have received wide publicity (79,80). The reports are, however, of limited use in assessing toxicity, because they are comprised of passively collected anecdotal data, which is often incomplete and unreliably reported. For example, one of the FDA ephedrine AERs "analyzed" in an article published in the New England Journal of Medicine described the sudden death of a teenage girl who had been born with a lethal cardiac malformation who died while playing volleyball (79). Postmortem blood and tissue tested negative for ephedrine, and the article failed to mention the existence of the cardiac malformation. In other AERs, massive doses of ephedrine were consumed (as with products intended for abuse, such as "herbal ecstasy," now withdrawn from the market). Toxicology testing was rarely performed in any of these cases, and it is not known with any certainty whether ephedrine was even taken. Even the authors of the two papers concede that anecdotal reports cannot be used to prove causality, stating that "Our report does not prove causation, nor does it provide quantitative information with regard to risk" (79). There is little point in reviewing material that cannot be used to prove causality, and it is not included in the summaries that follow, which are comprised only of published, peer-review case reports, epidemiological surveys, and controlled clinical trials. An additional review of the utility of spontaneously reported adverse events involving supplements and, more specifically, ephedra was published by Kingston et al. (81). The review discussed the limitations of spontaneously reported data in assessing supplement safety and determining causality between exposure and adverse effects.

Despite conflicting data regarding the safety of ephedra from clinical studies and conclusions drawn from spontaneously reported adverse events, FDA banned the sale of ephedra-containing supplements in 2004 (see Regulatory Status).

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