Adverse Drug Reaction Reporting: Comparison of Reports Received by a Specialized Registry and the Food and Drug Administration System

Abstract

To examine the utility of dermatology subspecialty reporting of adverse drug reactions for early detection of unusual reactions, reports of five drug-induced adverse reactions are reviewed: Fansidar and severe skin reactions, isotretinoin and spontaneous abortion and teratogenesis, isotretinoin and pseudotumor cerebrii, ketoconazole and fatal hepatic necrosis, and Piroxicam and photosensitivity. Reports from the registry are analyzed for completeness and timeliness and compared with reports received by the FDA's Spontaneous Reporting System (SRS). Reports from both systems proved to be comparable in terms of completing nine data elements examined on the adverse reaction reporting form. Registry reports, however, were received later than FDA reports.