Expedited approvals and adverse drug reactions in women (25 May 2024)

Summary

Over 65% of all new drugs undergo expedited drug approval in the USA, and these drugs have been linked to a higher prevalence of adverse drug reactions, raising concerns about safety. It is well documented that women generally report a higher frequency of adverse drug reactions than men, but whether women have more adverse drug reactions than men from drugs approved via expedited pathways is unknown. This brief Lancet article outlines the findings of a systematic review that assessed sex differences in data reporting and highlighted a knowledge gap as to whether women face a higher risk of harm through expedited approval pathways than men.