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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: Although Dr Lasser and colleagues1 made several general conclusions about the drug approval process and length of time that elapses between initial FDA approval and black box warnings regarding serious ADRs, the situation is more complex. We believe that the time between initial approval and appearance of black box warnings must be assessed on an individual basis. For example, with ganciclovir, the warning was "oral form not as effective as intravenous," and the lag time was noted as 6.5 years.1 However, ganciclovir was initially marketed as an intravenous formulation, and the oral form was not available commercially until several years after initial marketing of the intravenous form.2,3 Thus, using only the availability of the intravenous form as the benchmark artificially inflates the period when assessment of the efficacy of both formulations could have been adequately conducted.

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