Former finasteride users with sexual side effects at increased risk for depressive symptoms, suicidal thoughts

Finasteride is a commonly prescribed 5-alpha-reductase inhibitor used for the treatment of male pattern hair loss. In April 2012, FDA announced that labels of 2 formulations of finasteride, used to treat enlarged prostate and male-pattern baldness, were revised to indicate that additional sexual side effects may persist after the drug has been discontinued.

Finasteride 5 mg (Proscar, Merck) was approved by FDA in 1992 for the treatment of symptoms related to enlarged prostate. Finasteride 1 mg (Propecia, Merck) was approved by FDA in 1997 for the treatment of male-pattern hair loss in males only.

"Although the incidence of persistent sexual side effects in unknown, the potential risk of suicide is very serious and needs to be carefully considered," Dr Irwig told Formulary. "Men contemplating the use of finasteride and prescribers of finasteride need to be aware of its potentially serious side effects."

In 2010 to 2011, former users of finasteride with persistent sexual side effects for ≥3 months were administered standardized interviews. All former users were otherwise healthy men with no baseline sexual dysfunction, chronic medical conditions, current or past psychiatric conditions, or use of oral prescription medications before or during finasteride use. A control group of men, recruited from the community had male pattern hair loss but had never used finasteride and denied any history of psychiatric medications. The primary outcomes were the prevalence of depressive symptoms and the prevalence of suicidal thoughts as determined by the Beck Depression Inventory II (BDI-II); all subjects self-administered this questionnaire at the time of the interview or up to 10 months later.

Researchers at the George Washington University School of Medicine and Health Sciences, found that otherwise healthy men who developed persistent sexual side effects associated with finasteride had very high rates of depressive symptoms and suicidal thoughts as measured by the BDI-II.