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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: In their Editorial in response to the article by Dr Lasser and colleagues,1 Drs Temple and Himmel2 of the FDA stated, "it is incorrect to describe the introduction of unsafe drugs as frequent. . . . " Nevertheless, they recommended that "a physician contemplating prescribing a new drug should consider carefully the reason for the choice, particularly when an equally effective alternative is available. . . . "2

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