Post-market drug safety evidence sources: an analysis of FDA drug safety communications.

摘要

For over 40 years, spontaneous reporting of adverse events has been the cornerstone of Food and Drug Administration (FDA)'s post-approval drug safety monitoring system. Over time, clinical trials conducted after approval, as well as observational studies based on actual patient experiences, have also been the source of important drug safety evidence and have informed safety-related regulatory decision making (e.g. aprotinin and mortality; ESAs and mortality). Currently, the three primary postmarket drug safety evidence sources include clinical trials, spontaneous reports, and observational studies; data from pharmacodynamic and pharmacokinetic studies, registries, and other sources may also generate safety issues. Recent examples of drug safety issues, e.g. ADHD drugs and rosiglitazone and serious cardiovascular adverse events, delineate the fact that multiple evidence sources may contribute to the identification and evaluation of drug safety issues.