5α-Reductase Inhibitors May Increase Risk of Self-Harm, Depression in Older Men

Although the 5α-reductase inhibitors (5ARIs) finasteride or dutasteride are known to lead to improvements in men with benign prostatic hyperplasia (BPH), postmarketing data have suggested that men taking the medications might be at a greater risk of suicide and self-harm. A study published today in JAMA Internal Medicine has found that men 66 and older who took 5ARIs were not at a significantly increased risk of suicide. However, the risk of self-harm and depression in men taking these medications increased during the first 18 months of use compared with men not exposed to the medications. 

“The recognition of depression and self-harm as potential adverse effects of 5ARIs is important given their significant impact. However, the relatively small magnitude of these risks should not dissuade physicians from prescribing these medications in appropriate patients,” Blayne Welk, M.D., an assistant professor of surgery at Western University in London, Ontario, and colleagues wrote. “This research may help physicians counsel patients on the risks of 5ARIs.”

Belk and colleagues compared administrative data available for 93,197 men aged 66 and older in Ontario who started taking a 5ARI between 2003 and 2013 with an equal number of older men not prescribed these medications. During the study period, there were a total of 38 suicides, 169 incidents of self-harm, and 1,750 cases of depression among the participants taking a 5ARI. 

There was no difference in suicide risk between the groups, but among men exposed to 5ARIs, there was a significantly increased risk of self-harm (hazard ratio [HR]=1.88; 95% confidence interval [CI]=1.34-2.64) during the first 18 months of use; this risk of self-harm did not remain significantly elevated after the initial 18 months. There was also a significantly increased risk of depression (HR=1.94; 95% CI=1.73-2.16) during the first 18 months of use, and this risk continued to be elevated after 18 months, though to a lesser degree (HR=1.22; 95% CI=1.08-1.37). Men taking finasteride or dutasteride appeared to be at similar risk of suicide, self-harm, and depression.

Because the absolute risk of self-harm and depression was found to be low, the researchers noted “the potential benefits of 5ARIs in this population likely outweigh these risks for most patients. … Discontinuation of the 5ARI may be appropriate in the setting of new-onset depression or self-harm after the initiation of a 5ARI.”

The authors noted that additional studies are needed to determine the risk of suicide, self-harm, and depression in younger men prescribed finasteride for hair loss.

For related information, see the Psychiatric News article “Large Trial Suggests Testosterone Offers Moderate Benefits.”

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