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1986

Gerald A. Faich, MD, MPH; Michael Dreis, RPh, MPH; Dianne Tomita, MPH

Arch Intern Med. 1988;148(4):785-787.

Abstract
• The collection of adverse drug reaction (ADR) reports by the Food and Drug Administration serves to provide additional information on the toxic reactions of drugs that often cannot be known before a drug is marketed. In 1986, a total of 53 547 ADR reports were received; 56% of these were made by US health care professionals based on observations made during usual clinical practice. The 1986 total represents an increase of 14% in ADR reporting over 1985, continuing a trend begun in 1981. While these increases are encouraging, US reporting rates are far below many other countries, and further encouragement of reporting must be done. Of these ADR reports, 24% involved serious reactions and 20% involved new drugs. An ADR report should be seen as a professional responsibility; reports are carefully analyzed and used.

(Arch Intern Med 1988;148:785-787)

Author Affiliations
From the Office of Epidemiology and Biostatistics, Center for Drug Evaluation, US Food and Drug Administration, Rockville, Md.

Footnotes
Accepted for publication Dec 28, 1987.

The views expressed herein are those of the authors and are not to be construed as official, or as reflecting the views of the US Food and Drug Administration.

Reprints not available.

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