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December 22/29, 1999

Safety of FDA-Approved Drugs

Author Affiliations

Phil B.FontanarosaMD, Interim CoeditorIndividualAuthorMargaret A.WinkerMD, Deputy EditorIndividualAuthorStephenLurieMD PhD, Fishbein FellowIndividualAuthor

JAMA. 1999;282(24):2297-2298. doi:10.1001/jama.282.24.2297

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.