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Association of suicidality and depression with 5alpha-reductase inhibitors


Importance — There have been concerns raised by patients and regulatory agencies regarding serious psychiatric side effects associated with 5-alpha reductase inhibitors.

Objective — To determine if there is an increased risk of suicide, self-harm, or depression among older men starting a 5-alpha reductase inhibitor for prostatic enlargement.

Design — Population-based, retrospective, matched cohort study using linked administrative data.

Setting — Ontario, Canada from 2003 through 2013.

Participants — 93,197 men ≥66 years of age who initiated a new prescription for a 5-alpha reductase inhibitor during the study period were matched (using a propensity score which included 44 or our 96 covariates which included medical comorbidities, medication usage, and healthcare system utilization) to an equal number of men not prescribed a 5-alpha reductase inhibitor.

Exposure — Duration of finasteride or dutasteride usage.

Primary Outcome — Suicide. Secondary outcomes were self-harm and depression.

Results — Men who used 5-alpha reductase inhibitors were not at a significantly increased risk of suicide (HR 0.88, 95% CI 0.53 to 1.45). Risk of self-harm was significantly increased during the 4 initial 18 months after 5-alpha reductase inhibitor initiation (HR 1.88, 95% CI 1.34 to 2.64), but not thereafter. Incident depression risk was elevated during the initial 18 months after 5-alpha reductase inhibitor initiation (HR 1.94, 95% CI 1.73 to 2.16), and continued to be elevated, but to a lesser degree for the remainder of the follow-up period (HR 1.22, 95% CI 1.08 to 1.37). The absolute increase in the event rates for these two outcomes were 17/100,000 patient years and 272/100,000 patient years respectively. The type of 5-alpha reductase inhibitor (finasteride or dutasteride) did not significantly modify the observed associations with suicide, self-harm and depression.

Conclusions and Relevance — In a large cohort of men ≥66 years of age, we did not demonstrate an increased risk of suicide associated with 5-alpha reductase inhibitor use. However, the risk of self-harm and depression were increased compared to unexposed men. This is in keeping with post-marketing experience and patient concerns, and discontinuation of the medication in these circumstances may be appropriate.



Welk B, McArthur E, Ordon M, Anderson KK, Hayward J, Dixon S. JAMA Intern Med. 2017; 177(5):683-91. Epub 2017 Mar 20.

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