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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