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August 28, 2002

Postmarketing Surveillance and Black Box Warnings

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002

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

To the Editor: It is not surprising that Dr Lasser and colleagues1 found that serious ADRs are commonly discovered after the FDA has approved a new drug. The inherent limitations of clinical trials (ie, relatively small size, generally narrow study populations, narrow indication, and relatively short duration) significantly affect their ability to detect rare, serious ADRs,2 and are the raison d'être for postmarketing medical product monitoring. Similarly, it is known that a striking (at times, exponential) increase in patient exposure can occur once a drug comes to market. Patient populations (perhaps even an entire sex) who comprised little or none of the premarketing study group may undergo treatment with the drug.3

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