Internal documents from Merck & Co. reveal that the manufacturer of the anti-baldness drug Propecia (finasteride) knew about reports of suicidal behavior among people taking the drug and failed to warn doctors and patients of the risk. Last month, a federal magistrate judge in New York granted a motion to unseal a number of previously confidential documents produced in discovery in litigation alleging Propecia caused persistent sexual dysfunction and other harmful side effects.
In 2009, Merck performed a “risk management assessment” and learned of more than 200 reports of depression, including suicidal thoughts, in men taking the drug. Notably, European and Canadian regulators now require the drug's labeling to contain a warning of suicidal thoughts, while the U.S. label does not contain a similar discussion of the risk. Since 2011, the FDA has received over 700 reports of suicide or suicidal thoughts, including 100 deaths, among people taking the drug.
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