Adverse drug reaction processing in the United States and its dependence on physician reporting: zomepirac (Zomax) as a case in point.
Because of limited premarket testing for drugs newly approved by the FDA, serious but rare side effects may not be apparent or publicized by the drug manufacturers. Therefore, only the timely reporting of adverse drug reactions by physicians, along with rapid recognition of the significance by the FDA, can ensure the effectiveness of the FDA Spontaneous Reporting System as a warning to other prescribing physicians. The experience with zomepirac (Zomax) and the unexpected incidence of severe anaphylactic reactions is recanted as an unfortunate illustrated example that has served to upgrade the adverse reaction reporting process.
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Department of Emergency Medicine, Cedars-Sinai Medical Center, Los Angeles, California 90048.
Spielberg
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D000465:Algorithms; D000707:Anaphylaxis / Q000139:chemically induced / Q000401:mortality; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D004346:Drug Information Services; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions; D005069:Evaluation Studies as Topic / Q000592:standards*; D006801:Humans; D010819:Physician's Role; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D011758:Pyrroles / Q000009:adverse effects*; D012380:Role; D014046:Tolmetin / Q000009:adverse effects* / Q000031:analogs & derivatives; D014481:United States; D014486:United States Food and Drug Administration
D000894:Anti-Inflammatory Agents, Non-Steroidal; D011758:Pyrroles; C020549:zomepirac; D014046:Tolmetin