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.