While crafting the language for the 2011 update to the label for its flagship hair loss drug Propecia, Merck was aware of a stunning number of reports of suicide among those taking the drug. Yet today, even though the FDA has records of over 700 reports of suicide or suicidal thoughts related to Propecia or its generics, Propecia’s label makes absolutely no mention of depression or an increased risk of taking one’s own life. At least 100 of those reports are actual fatalities.
This information comes as a result of an explosive report out of Reuters. The news agency was finally able to unseal documents it had requested in 2019 that were filed during years-long litigation over Propecia’s possible sexual side effects. These included side effects that persisted even after the patient stopped taking the drug.
Propecia is incredibly popular. Over 2.4 million prescriptions for the medication were written in 2020. This more than doubles the number written just five years prior. Yet, as reports rolled in as early as 2009 of over 200 cases of depression and suicidal thoughts possibly attributed to its use, Merck’s internal “risk management” assessments concluded that not enough information existed to make any changes to the label.
Two years later, after Merck went to the FDA over the possibility of adding depression as a possible Propecia side effect, the agency concluded that data on the issue of suicide was not sufficient to warrant any changes. The decision puts the FDA at odds with both European and Canadian health regulators who have required warnings about depression and possible suicidal ideation on Propecia labels for years, even though they simultaneously state that a conclusive link doesn’t yet exist. Still, the mere risk of such a possibility is enough to make these regulators move to protect the safety of their citizens.
One has to wonder why the FDA’s priorities appear to be reversed and seemingly valuing the profits of the corporations it’s supposed to be monitoring over the lives of the citizens it’s supposed to be protecting.
The Reuters investigation can be read in its entirety at their site.