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To the Editor: Dr Friedman and colleagues¹ downplayed serious safety questions about dexfenfluramine, mibefradil, and bromfenac sodium, which were approved in 1996-1997 and subsequently removed from the market, that were raised prior to marketing. Furthermore, Friedman et al failed to acknowledge that these drugs did not represent significant advances over the numerous approved drugs in their therapeutic categories.

For example, data from congestive heart failure trials presented at a Food and Drug Administration (FDA) Advisory Committee meeting on mibefradil suggested that more patients treated with mibefradil died than those taking placebo.² Several committee members voted against approval. The drug, the ninth calcium channel blocker approved in the United States, has since been removed from the market because of life-threatening arrhythmias from drug interactions.³

The FDA medical officer reviewing bromfenac sodium, the 20th nonsteroidal anti-inflammatory drug (NSAID) approved in the United States, unsuccessfully advocated a black box warning label as a . . . [Full Text of this Article]

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