Mortality and adverse events with brand and generic clopidogrel in the US Food and Drug Administration Adverse Event Reporting System

Clopidogrel, as a brand or generic formulation, remains a dominant constituent of current dual antiplatelet strategies, but their comparative efficacy and safety remain unknown.(1,2) Dr Serebruany has assessed primary causative adverse events (PCAE) after brand or generic formulation in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). In this study, death reports were higher with brand formulation, but the rates of cardiac, haemorrhagic, and skin complications were less common for brand formulation clopidogrel. The authors concluded that there is an expected reporting bias, which may indicate that the manufacturers of generic formulation clopidogrel under-report deaths to the FDA, while the overall adverse event profile suggests potentially better safety of brand formulation over generic formulations.