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August 28, 2002

Postmarketing Surveillance and Black Box Warnings

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

To the Editor: Dr Lasser and colleagues1 concluded that the safety of a new agent cannot be known with certainty until it has been on the market for several years. They defined a serious ADR according to changes in the Physicians' Desk Reference. The most common causes of such changes were hepatic toxicity, hematologic toxicity, and cardiovascular toxicity. We believe that the problem of drug safety may be even greater than Lasser et al suggest.

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