FDA quashed internal warning on suicidality linked to Propecia; changed course in 2022

KEY POINTS In 2010, Merck requested to add ‘depression’ to adverse events in the Propecia label. A safety group within FDA concurred, and also recommended adding ‘suicidal thoughts and behavior.’ FDA’s dermatology products group did not support adding a suicidality warning. Only ‘depression’ was added to the label in 2011. Over a decade later, in … Read more