Adverse Drug Reactions and the Food and Drug Administration

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Abstract
The monitoring of adverse drug reactions (ADRs) after a drug is marketed is an important mission for the US Food and Drug Administration (FDA). Currently, the FDA receives and computerizes nearly 60,000 ADR reports each year. The FDA has an active postmarketing surveillance system in place to effectively triage, tabulate, analyze, and evaluate these reports. Of highest priority to FDA are the discovery of serious reactions that were not observed before a drug was marketed and the detection of increased occurrence of serious reactions that are known to occur with the drug. All reactions for new moieties marketed in the United States during their first 3 years are of interest. Pharmacists are in a unique position to be aware of adverse reactions because of their knowledge of drugs, their close working relationships with other health care providers, and their direct interactions with patients. By participating in FDA's ADR reporting system, pharmacists can actively contribute to drug safety and help improve patient care. This is a US government work. There are no restrictions on its use.

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