Outrage of the Month: Merck, FDA Failed to Warn Consumers About Potential Suicide Risk Linked to Anti-Baldness Drug

Health Letter, March 2021

By Michael Carome, M.D.

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According to a troubling report published by Reuters on Feb. 3, drugmaker Merck & Co. and the Food and Drug Administration (FDA) for years have been aware of hundreds of reports of suicidal thoughts (ideation) and behavior in men taking the company’s anti-baldness drug Propecia, but failed to add a warning about this potential risk to the drug’s U.S. product labeling.

Propecia is the original brand name for the low-dose (1-milligram [mg]) form of finasteride — an oral prescription drug that belongs to a drug class called 5-alpha-reductase inhibitors, which block the conversion of testosterone to the more potent androgen dihydrotestosterone. It was approved by the FDA in 1997 for treatment of male-pattern hair loss in men only. A high-dose (5-mg) form of finasteride, which is sold under the brand name Proscar, had been approved by the FDA in 1992 for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The Reuters report was based on recently unsealed internal documents from Merck related to litigation alleging that Propecia caused persistent sexual dysfunction and other harmful adverse effects. These documents revealed that by 2009, Merck knew of more than 200 reports of depression, including some that involved suicidal thoughts, in men treated with Propecia. Other records obtained from the FDA by Reuters showed that prior to 2011, the agency had received 34 reports of suicide or suicidal thoughts associated with use of the low-dose finasteride. In ten of these cases, the patient had died.

Reuters noted that in 2010, while the FDA was considering a request from Merck to add the potential risk of “depression” — but not “suicidal thoughts and behavior” — to the product labeling for Propecia, an agency safety reviewer recommended that a warning about suicidal thoughts and behavior also be included. However, two FDA medical reviewers disagreed with adding such a warning.

When the FDA approved revisions to the drug’s product labeling in 2011, a very brief statement buried deep in the label was added noting only that there had been reports of depression in patients using the drug after it was approved. There was no mention in the revised labeling of the reports of suicidal thoughts and behavior.

According to the Reuters report, since the product labeling changes in 2011, the FDA has received more than 700 reports of suicide and suicidal thoughts, including at least 100 deaths, in men treated with Propecia or generic versions of the drug. Similar reports prompted the European Medicines Agency to require the addition of a warning about the risk of suicidal thoughts to the product labeling for the low-dose form of finasteride in 2017. Health Canada took similar action in 2019.

Disturbingly, the most recently updated product labeling for the drug, which was approved by the FDA in 2014, lacks any warning about the potential risk of suicidal thoughts and behavior associated with use of the drug.

Physicians prescribing and patients taking Propecia for baldness, a non-serious cosmetic condition, must be warned about the drug’s potential risk of suicidal thoughts and behavior. The FDA’s yearslong failure to mandate that Merck include such warnings in the drug’s U.S. product labeling is unconscionable and represents a dereliction of its duty to protect public health.