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terfenadine (SELDANE)


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Statement about a Food and Drug Adminstration article in the Journal of the American Medical Association regarding recently withdrawn drugs and the safety of newly approved drugs. (HRG Publication #1481)
None of these drugs were breakthrough drugs and the serious safety concerns should have prevented their approval in the cases of Redux, Posicor, and Duract and a much earlier market withdrawal for Seldane. FDA's conclusion that there is no problem associated with these drug safety withdrawals should not be taken seriously because to do so will continue to jeopardize the safety of American patients.