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

Adverse effects on the Propecia label: a history of changes

In its Drugs@FDA database, FDA has at least nine versions of the Propecia label going back to 2001. This post will trace the history of changes to adverse effects in the label for consumers. A summary of label changes: 2001 – “Side effects went away in men who stopped taking Propecia” 2002 – Testicular pain … Read more