Identification of adverse reactions to new drugs. II--How were 18 important adverse reactions discovered and with what delays?

Concepts

PharmacyPharmacologyDrug Approval ProcessesPharmacovigilancePharmacovigilance PolicyAdverse Drug Reaction DetectionAdverse Drug Reaction ReportingAdverse Drug ReactionsAdverse Event ReportingCausality AssessmentDrug Safety MonitoringAdverse Drug EventsAdverse Drug Reaction AnalysisAdverse Drug Reaction EpidemiologyAdverse Drug Reaction RecognitionAdverse Drug Reaction SurveillanceAdverse Reactions ReportingSuspected Adverse Drug Reaction ReportingSuspected Adverse Reaction Assessment

Abstract

The process of discovery of 18 important adverse drug reactions was reviewed. For each adverse reaction the dates were noted of the report which first alerted the medical profession to the suspected reaction, the report which resulted in verification of causality beyond reasonable doubt, and the first regulatory action or warning to the medical profession in Britain by the Committee on the Safety of Medicines.