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August 28, 2002

Postmarketing Surveillance and Black Box Warnings—Reply

JAMA. 2002;288(8):955-959. doi:10.1001/jama.288.8.955

In Reply: We agree with Dr Graham that in some cases it may be difficult to identify ADRs before large numbers of patients are exposed to a drug. Increasing the number and diversity of patients enrolled in clinical trials would expedite detection of ADRs. In some instances, however, serious ADRs are detected prior to drug approval, yet the drug is still approved. The FDA approved both alosetron and grepafloxacin despite the fact that the drugs caused ischemic colitis and QT prolongation in preapproval trials, respectively.1 However, unless a new drug is a breakthrough drug, we would question the wisdom of exposing thousands or even millions of patients to it, given that 20% of new drugs will ultimately be found to have serious ADRs.1

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