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According to court records recently obtained by Reuters News, Merck has known for years about reports involving problems with suicidal thoughts and ideation following use of the hair-growth drug Propecia, but decided not to update the drug warning label.
In an investigative report published last week, Reuters indicates that reports involving Propecia suicide problems among men were received before 2011, when the manufacturer decided not to add a label warning to the drug.
By that time, the FDA has received at least 34 reports involving suicide and suicidal thoughts that may have been linked to side effects of Propecia, including at least 10 deaths. Since refusing to add the warning, the FDA received more than 700 additional reports about the problems.
Propecia (finasteride) is a prescription medication marketed by Merck to help men restore natural hair loss that occurs with male pattern baldness. The active pharmaceutical ingredient was originally developed by Merck as a niche treatment for enlarged prostate, and marketed as Proscar in 1992. It was later approved to treat male pattern baldness, when it was given the brand name Propecia and aggressively marketed in direct-to-consumer advertisements encouraging men to contact their doctors about the prescription.
The new report notes there were 2.4 million Propecia prescriptions filled in 2020, which is twice that prescribed in 2015. However, while label warnings on Propecia suicide risks were added in Europe and Canada years earlier, no such warning has been added to U.S. labels.
In 2009, Merck had already received more than 200 reports of depression, including suicidal thoughts, linked to Propecia use. Those findings were outlined in an internal risk assessment report within the company that same year. However, Merck executives determined there were not enough of such reports to merit a label warning.
Propecia Side Effects
While men generally take the medication to help improve their appearance and overall quality of life, the drug maker previously faced a number of Propecia lawsuits filed by men who allege that they have been left with permanent sexual complications, such as erectile dysfunction, decreased libido, genital shrinkage and problems with cognition.
According to allegations raised in the complaints, Merck has failed to adequately warn consumers or the medical community about the link between Propecia and sexual dysfunction, which may continue long after the medication is no longer used.
Prior warning information provided by the drug maker suggested that sexual dysfunction associated with the medication was rare, and that the problems resolve after use of the medication is discontinued.
Even after many men reported experiencing permanent sexual issues after Propecia use, Merck continued to provide information suggesting that the problems were temporary until the Propecia sexual dysfunction warning label was updated in April 2012. While the warning included the risk of sexual dysfunction, it did not include warnings for suicide risks.