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August 1991

National Adverse Drug Reaction Reporting: 1984-1989

Author Affiliations

From the Office of Epidemiology and Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md. Dr Faich is now with the Philadelphia Association for Clinical Trials, St Davids, Pa. The opinions expressed are those of the author and do not necessarily reflect the Food and Drug Administration policy.

Arch Intern Med. 1991;151(8):1645-1647. doi:10.1001/archinte.1991.00400080129025

Surveillance of adverse reactions due to pharmaceuticals is important because the drug approval process cannot totally assure safety and because new knowledge is bound to accrue after drugs enter usual medical practice. Reporting of reactions to the Food and Drug Administration increased markedly between 1985 and 1989 and totaled 261 515 reports for this period. A large part of this increase was due to new legal requirements, which ensure that manufacturers report reactions to the Food and Drug Administration. Most reaction reports originated with practicing physicians who contacted drug manufacturers. High proportions of the reports involved new drugs and serious reactions. Reaction surveillance leads to 50 to 100 important safety investigations annually and to numerous changes in product information. Health care providers must continue to report suspect adverse reactions to the Food and Drug Administration and manufacturers if pharmaceutical use and safety are to improve.

(Arch Intern Med. 1991;151:1645-1647)

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