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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: As Dr Graham, Dr Goldman, and Drs Greene and La Vaque point out, the population treated with a drug is more diverse than the population in which it was initially studied. Nonetheless, the most serious ADRs, such as those identified by Lasser et al,1 seem best explained by the much more extensive use after marketing and not by the greater diversity or comorbidity of the treated population, with some important exceptions. In premarketing clinical trials, drugs known to interact with the test drug would be scrupulously avoided; this avoidance is not ensured once the drug is marketed. In addition, few new drugs are studied in pregnant women. Of the ADRs identified by Lasser et al leading to box warnings or withdrawal, few (perhaps suprofen, used in dehydrated patients or some of the QT-prolonging drugs, used in patients with prolonged QT prior to taking the drug) seem principally related to the larger numbers of people receiving drugs in society.

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