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The process of approving new drugs has changed substantially in recent years, and there is concern that late detection of adverse drug reactions may result in harm to patients. Researchers, including representatives from a patient-advocacy group, studied the Physicians' Desk Reference to determine the incidence of black-box warnings (denoting the most severe adverse reactions) and the frequency and timing of drug withdrawals from the market.
Of 548 new chemical entities that were approved from 1975 through 1999, 45 (8%) acquired black-box warnings, and 16 (3%) were withdrawn from the market (5 withdrawn drugs also received black-box warnings). Half the withdrawals occurred within 2 years after drug introduction. There were 81 major changes t…