Newly released court documents show concerns over a link between suicidal behavior and the popular anti-baldness drug Propecia have been present for a decade.
Despite those worries, the drug’s manufacturer, Merck & Co., and U.S. regulators decided against warning consumers of the risks when the drug’s label was updated in 2011.
Side effects outlined in internal documents
In late January, responding to a 2019 motion by Reuters, a federal magistrate unsealed internal documents from Merck related to litigation against the company, claiming Propecia caused sexual dysfunction along with other harmful side effects.
Since deciding against adding a warning to the drug’s label related to suicide in 2011, the FDA has received over 700 reports of suicide or suicidal thoughts by people taking Propecia, and its generic version, finasteride. Those reports included more than 100 deaths.
From 1997, when the drug was approved, until 2011, the FDA received 34 such reports, which included 10 suicides. Health data company IQVIA reports 2.4 million prescriptions were issued for the hair loss drug in 2020, more than double the number in 2015.
Regulators considered but ultimately dismissed warnings
Merck’s internal documents show the company was aware of nearly 200 reports of depression among Propecia-users by 2009 but considered the number as “too low” to merit a warning. In 2011, the FDA considered adding a warning for depression, but regulators eventually agreed with the drugmaker.
Meantime, Canadian and European drug regulators, who cited similar complaints, require warnings on the drug’s labels over suicidal thoughts. The European Medicines Agency has required the warning since 2017, and Health Canada added its own advisory in 2019.
The new information adds to longstanding concerns over the drug causing sexual dysfunction in men. More than 1,100 lawsuits were filed against Merck, mostly by men who said they continued having sexual problems long after they stopped taking the drug. Merck settled most of those cases in 2018.