Study of depression from prostate drugs loses the signal by including past users

This study fails to assess the risk of depression associated with using finasteride or dutasteride because past users of 5-ARIs were counted as cases. 37% of cases in the 5-ARI group had stopped taking the drug 181 days or more prior to initial diagnosis or treatment for depression. Only slightly more than half of cases were current users at the time of initial diagnosis or treatment for depression. Moreover, the control group was taking ⍺-blockers.

Response to Campbell et al on finasteride-associated suicide and depression in men treated for hypogonadism and impotence

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.

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.