Response to: Hagberg KW, Divan HA, Nickel JC, Jick SS. Risk of incident antidepressant-treated depression associated with use of 5α-reductase inhibitors compared with use of α-blockers in men with benign prostatic hyperplasia: a population-based study using the Clinical Practice Research Datalink. Pharmacotherapy. 2017. doi:10.1002/phar.1925 SUMMARY: Hagberg et al, 2017 fails to assess the risk of … 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.