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Ephedra FDA

The Food and Drug Administration (FDA) signaled that it attempt to ban ephedra dietary supplements again.

According to the FDA, ephedra poses "a significant or unreasonable risk of illness or injury." That phrase is open to interpretation, but the risk posed by ephedra seems quite modest when compared to the risks associated with widely used over the-counter and prescription drugs.

 

Although press reports commonly cite an estimate of "at least 150 deaths" linked to ephedra, a RAND Corporation study commissioned by the FDA found only two documented deaths that were investigated to rule out other causes. Even in those cases, the FDA concedes, the evidence is not conclusive.

Up to 17 million Americans taking something like 3 billion doses of ephedra products a year. FDA Administrator Mark McClellan admits that "serious adverse events from ephedra appear to be infrequent."

That point is underlined by data from the federal government's Drug Abuse Warning Network. Selected DAWN numbers for 1999 indicate that two deaths over several years would not make ephedra stand out on a list of drugs mentioned by medical examiners.

Ephedra FDA

DAWN Medical Examiner Mentions (1999) Deaths Caused by Drugs
Drug Mentions 
diazepam (Valium) 811
diphenhydramine (Benadryl) 641
Elavil (antidepressant)477
nortriptyline (antidepressant)424
acetaminophen (Tylenol)  427
lidocaine (heart drug & local anesthetic)384
Prozac 305
quinine 250
meprobamate (tranquilizer)170
aspirin 104


Source: Drug Abuse Warning Network

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