Finasteride, a widely-used treatment for hair loss, has been linked with depression and suicide for over 20 years. Despite this, however, the drug’s manufacturer and regulators have not launched safety investigations into the drug. The issue was highlighted by a narrative review published in the Journal of Clinical Psychiatry.
"The evidence is no longer anecdotal," said author of the review, Prof. Mayer Brezis, a professor emeritus of medicine and public health at the Hebrew University of Jerusalem, in a press release, "We now see consistent patterns across diverse populations. And the consequences may have been tragic."
"This wasn't about life or death medical necessity. This was about hair,” he added.
In the review, Brezis analyzed data from eight large studies published between 2017 and 2023. He found that finasteride was linked to a significantly higher risk of depression, anxiety, and or/ suicidal behavior. The pattern was consistent among various national databases from the FDA's adverse event system to health records from Sweden, Canada, and Israel.
The drug was originally approved by the FDA in 1997 for male pattern baldness. While researchers had been warning about the drug’s potential dangers since 2002, the FDA only recognized depression as a possible side effect in 2011 and added suicidal thoughts to its label in 2022.
“Over 20 years worldwide, hundreds of thousands may have endured depression, and hundreds may have died by suicide. According to the precautionary principle, such a risk from a cosmetic medication suggests a benefit-to-harm balance that justifies action to protect the public, and the burden of proving that the intervention is not harmful falls on manufacturers,” wrote Brezis in the review.
He is calling for immediate changes to how drugs like finasteride are approved, monitored, and prescribed. He recommends suspending marketing of the drug for cosmetic purposes until its safety has been re-established as well as mandatory post-marketing studies with strict enforcement and systematic recording of drug histories in suicide investigations.
"For many, those changes come too late. The paper is dedicated to one such individual -- a previously healthy man who took finasteride "just" to improve his hair. Within days, he spiraled into severe psychiatric distress. He never recovered. Months later, he took his own life,” said Brezis.
Sources: Science Daily, Journal of Clinical Psychiatry