Prescrire, an independent patient safety organization based in France, has updated its Drugs to Avoid guide. Finasteride appears in the 2024 edition, and has also been included in past editions. The guide notes: Finasteride 1 mg, a 5-alpha reductase inhibitor, has very modest efficacy in androgenic alopecia in men: it increases hair density on the … Read more
The clear and concerning results in this abstract are statistically significant RORs for suicidal and self-injurious behaviors, anxiety disorders and depressed mood disorders in the finasteride-only group. The suggestion that combination therapy could “decrease” risk or have a “protective” role is unwarranted because the risk ratios are derived from unrelated sets of cases. This study seems to treat pharmacovigilance data as if it were a controlled, prospective study, when the data is uncontrolled and retrospective.
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.