January 1987

Toxicity of Nonsteroidal Anti-inflammatory Drugs

Author Affiliations

Department of Medicine Medical College of Wisconsin 8700 W Wisconsin Ave Milwaukee, WI 53226

Arch Intern Med. 1987;147(1):34-35. doi:10.1001/archinte.1987.00370010038008

The literature on toxicity of nonsteroidal anti-inflammatory drugs (NSAIDs) is confusing. Much of the data relied on by pharmaceutical companies and the Food and Drug Administration comes from so-called Phase Three Trials. These are double-blind, controlled trials, usually of relatively brief (three months or less) duration. The test drug is compared to a standard drug or, less commonly, to a placebo. These studies produce highly reproducible findings; for example, the percent of subjects with gastrointestinal (GI) tract symptoms after ingestion of a given NSAID does not vary greatly from study to study. Using these studies, we know that all NSAIDs produce GI tract symptoms, ranging from 30% with uncoated aspirin to 10% or less with the newer NSAIDs. The limitations of these studies is that they involve relatively small numbers of patients, so that rare but very serious side effects would be missed. Another major

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