KEY POINTS

  • Merck & Co.'s anti-baldness drug may cause depression and suicide in men
  • The FDA decided against warning consumers about potential risks associated with the drug in 2011
  • A 2009 assessment found more than 200 reports of suicidal thoughts among men taking Propecia

A treatment commonly used to prevent hair loss may be cause depression and suicide among men, records show.

Newly unsealed court documents and records reportedly showed that Merck & Co.’s male-pattern baldness drug Propecia was linked to a string of suicides.

U.S. health regulators knew about the reports of suicidal behavior in men. The U.S. Food and Drug Administration did not include potential risks of taking the drug in a 2011 update of Propecia’s label after analysts dismissed the need to add a suicide warning.

Internal records from Merck were made public in late January after a federal magistrate in New York granted a request to unseal at least 11 litigation documents filed against the drug company. In many of the records, people complained about suffering from sexual dysfunction and other side effects after taking Propecia or generic versions of the medication.

The FDA has received over 700 reports of suicide or suicidal thoughts among people who ingested the medicine following its decision 10 years ago to not issue a warning to consumers. At least 100 deaths were reported.

Court records also revealed that Merck conducted an internal “risk management” assessment in 2009 that found over 200 reports of depression and suicidal thoughts among men taking the hair loss treatment. However, the company said there weren't enough reports of severe cases of depression and suicidal behavior, and not enough specifics about those cases, to justify more than standard tracking of safety information, Reuters noted.

“The scientific evidence does not spport a causal link between Propecia and suicide or suicidal ideation and these terms should not be included in the labeling,” Merck said in a statement released to Reuters. “Merck works continuously with regulators to ensure that potential safety signals are carefully analyzed and, if appropriate, included in the label for Propecia.”

In November 2020, a team from the division of urologic surgery at Brigham and Women’s Hospital in Boston said they found multiple reports of suicidal ideation over the past decade among young men using Propecia. The reports surged after 2012.

"Patients should be made aware of this potential side effect and speak to their prescribing doctor if they have concerns," senior researcher Dr. Quoc-Dien Trinh said.

A view of the Merck & Co. campus in Linden, New Jersey
Drug giant Merck agrees to pay $950 million to settle a criminal case and civil claims over its Vioxx painkiller. Reuters