Evaluation of Serious Adverse Drug Reactions

Charles L. Bennett
2007 Archives of Internal Medicine  
The Food and Drug Administration (FDA) and pharmaceutical manufacturers conduct most postmarketing pharmaceutical safety investigations. These efforts are frequently based on data mining of databases. In 1998, investigators initiated the Research on Adverse Drug events And Reports (RADAR) project to investigate reports of serious adverse drug reactions (ADRs) and prospectively obtain information on these cases. We compare safety efforts for evaluating serious ADRs conducted by the FDA and
more » ... ceutical manufacturers vs the RADAR project. Methods: We evaluated the completeness of serious ADR descriptions in the FDA and RADAR databases and the comprehensiveness of notifications disseminated by pharmaceutical manufacturers and the RADAR investigators. A serious ADR was defined as an event that led to death or required intensive therapies to reverse. Results: The RADAR investigators evaluated 16 serious ADRs. Compared with descriptions of these ADRs the completeness and timing of dissemination of safety notifications. Moving forward, collaborations could be developed that build on the strengths of independent nonprofit organizations that proactively conduct pharmacovigilance efforts and of safety efforts of the FDA and pharmaceutical manufacturers.
doi:10.1001/archinte.167.10.1041 pmid:17533207 fatcat:nrkw755ibrhs3mss2drjvaqh4m