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April 1986

Adverse Drug Reactions: The Clinician's Role in Reporting

Author Affiliations

Section of Allergy-Immunology Department of Medicine Northwestern University Medical School 303 E Chicago Ave Chicago, IL 60611

Arch Intern Med. 1986;146(4):649-650. doi:10.1001/archinte.1986.00360160051003

The early recognition of allergic and other adverse effects to new drugs may reduce morbidity—and, on occasion, mortality—following their introduction into widespread clinical usage. Similarly, careful evaluation of a suspected adverse effect may prevent inappropriate incrimination of a potentially useful therapeutic agent.

Despite a generally good safety record for modern drugs, there are incontrovertible reasons why the possibility of adverse drug effects cannot be predicted prior to extensive use in humans. Preliminary animal testing can be expected to demonstrate direct, dose-related effects, but the rodents (and occasionally other animals) that are used are usually inbred strains, in which the response is often uniform due to genetic homogeneity. Humans, by contrast, are outbred. Moreover, no animal species, not even among the primates, metabolizes drugs by routes and at rates similar enough to those of humans to serve as reliable models. This is further compounded by individual differences in human response as