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The recent article by Castellana and Chiappetta presents data collected from the FDA Adverse Event Reporting System (FAERS) illustrating a long-standing but still insufficiently addressed issue: women experience adverse drug reactions at significantly higher rates than men. The reported 1.5-fold increased risk should, however, be interpreted with great caution due to the limitations of Adverse Event Reporting Systems, such as differential over-reporting and confounding factors. The 12% of missing gender data in this database also raises a notable concern.1