Merck knew anti-baldness drug Propecia had risk of suicidal behavior - Business Insider

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Merck knew about suicidal behavior in men taking anti-baldness drug Propecia, yet failed to warn consumers of these risks

Merck knew of reports of suicide in men taking the firm's anti-baldness treatment Propecia.Reuters reported the news, revealed in unsealed court documents and other records. - Newly unsealed court documents and other records show that Merck & Co and U.S. regulators knew about reports of suicidal behavior in men taking the company's anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug's label.

European and Canadian regulators, citing similar reports among men taking finasteride, require a warning of suicidal thoughts on the label, though they note that research has not proved that the drug causes such thoughts. To this day, the U.S. label contains no mention of suicide or suicidal thoughts.A biotech known for its sleep and brain drugs just made a $7.

Michael Irwig, an endocrinologist and Harvard Medical School faculty member whose own research has found possible links between finasteride and suicidal behaviors, said Merck's handling of the risk analysis and the FDA's inaction keep critical information from the public. Merck"definitely should have provided a more complete picture," Irwig said.

The Reuters investigation found that hundreds of thousands of Americans have been killed or seriously injured in recent decades by allegedly defective products -- including drugs, cars and medical devices -- while evidence that could have alerted consumers and regulators to potential danger remained hidden.

In her November 2010 report, FDA safety evaluator Namita Kothary wrote that the nine suicides were difficult to assess due to incomplete information."However, we cannot exclude that finasteride may have contributed to the events," she wrote. Kothary did not respond to requests for comment. The FDA approved Propecia in 1997, and sales climbed steadily through the 2000s, peaking at $447 million in 2010. Soon after, Merck's patent expired. Overall sales of finasteride have remained strong as cheaper generic versions have hit the market.The new information regarding a potential suicide risk emerged as a result of longstanding controversy about sexual problems associated with the drugs.

Reuters reported in 2019 that prior to the settlement, plaintiffs' lawyers had alleged that Merck, when revising the drug's original label, understated the number of men who experienced sexual symptoms in clinical trials and how long those symptoms lasted. The allegation was part of a sealed court brief a Reuters reporter was able to read because of a redaction error. The brief cited internal Merck communications, filed under seal.

 

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