Suicidality, Depression Risk with BPH Drugs Examined

The data showed adult males who used 5 alpha-reductase inhibitors did not exhibit a significantly increased risk of suicide, however the risk of self-harm did increase.

Findings from a retrospective, matched cohort study found a higher risk of self-harm and depression but no increased risk of suicide associated with 5 alpha-reductase inhibitor use compared to unexposed patients. The results of this study are published in JAMA Internal Medicine.

The concern with 5 alpha-reductase inhibitors use and serious psychiatric adverse effects has been raised by patients and regulatory bodies. To assess if there is an increased risk of suicide, self-harm or depression among older men initiating 5 alpha-reductase inhibitor for prostate enlargement, study authors conducted a study of administrative data for 93,197 men (aged ≥66 years) in Ontario, Canada. Qualified patients had to have started a new prescription for a 5 alpha-reductase inhibitor (finasteride or dutasteride) during 2003–2013. These patients were then propensity-matched to an equal number of men who were not prescribed a 5 alpha-reductase inhibitor. 

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The main outcome measure was suicide; secondary outcomes included self-harm and depression. The data showed adult males who used 5 alpha-reductase inhibitors did not exhibit a significantly increased risk of suicide (hazard ratio [HR] 0.88, 95% CI: 0.53–1.45). The risk of self-harm, however, was significantly higher during the initial 18 months after starting 5 alpha-reductase therapy (HR 1.88, 95% CI: 1.34–2.64), but not thereafter. 

The risk of incident depression was also increased during the first 18 months after 5 alpha-reductase inhibitor initiation (HR 1.94, 95% CI: 1.73–2.16) and remained elevated for the rest of the follow-up period (HR 1.22, 95% CI: 1.08–1.87). 

Study authors reported the absolute increases in the event rates to be 17 per 100,000 patient-years for suicide and 237 per 100,000 patient-years for self-harm and depression.

Moreover, the type of 5 alpha-reductase inhibitor—finasteride or dutasteride—was not found to significantly alter the observed associations with suicide, self-harm, and depression. Lead author, Blayne Welk, MD, MSc, added, “This is in keeping with postmarketing experience and patient concerns, and discontinuation of the medication in these circumstances may be appropriate.”

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