Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002

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Abstract
A primary mission of the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA) is the review and approval for marketing of safe and effective drugs and certain biologic agents. Before approval, drugs are evaluated for a defined indication in clinical trials of relatively short duration in a relatively small number and in restricted categories of people. Following approval and marketing, when the drug is used in larger populations for longer durations and for unapproved indications, previously unidentified adverse drug eventsoften occur. Some of these events have been serious and frequent enough or have altered the risk-benefit ratio enough to result in the drug’s removal from the market.