Regulators are waking from their slumber
Agencies in France, the United Kingdom, Canada and the United States are strengthening warnings about finasteride risks
Drug label
FDA quashed internal warning on suicidality linked to Propecia; changed course in 2022
In 2010, Merck requested to add a warning of depression to the Propecia label. A safety group within FDA concurred, but FDA’s dermatology products group did not support the change. Over a decade later, FDA required the addition of ‘suicidal ideation and behavior’ to the Propecia label.
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
2012 revision of Propecia label contained new warnings, even though FDA said it didn’t
It seems the 2012 statement from FDA — that these labeling changes are not new warnings — was incorrect.