Consumer-rights law firm Hagens Berman has filed a first-of-its-kind lawsuit accusing Merck & Co. (MRK) for allegedly failing to warn of the dangerous side effects like suicidality and suicide ideation of its prescription hair loss drug Propecia, which contains the active ingredient finasteride.
Hagens Berman is representing surviving family members of a person who spiraled into a deep depression followed by suicide ideation while taking Propecia in 2008, which eventually led him to take his own life even after he stopped taking the drug in 2012.
Approved by the FDA in 1997 for male pattern baldness, Propecia's label has warned of sexual side effects, but carried no warning whatsoever about the risks of depression and suicidal thoughts through 2010.
It was only by late 2010 that Merck updated Propecia label to include the risk of depression. However, to this day, the drug's label fails to warn of the risks of suicidal ideation and increased suicidal behavior, despite reports of depression and suicide ideation in clinical studies, alleges the lawsuit.
Sales of Propecia have declined since 2011 as can be seen by the numbers - $447 million in 2011; $424 million in 2012; $283 million in 2013 and $264 million in 2014.
Proscar, another drug developed by Merck, also contains finasteride, the same active ingredient as in Propecia. Proscar was approved by FDA in 1992 to treat benign prostatic hyperplasia.
Both Propecia and Proscar are already the subjects of several lawsuits over sexual side effects. In 2012, many individual Propecia lawsuits over sexual problems were consolidated into a multi-district litigation in Eastern District of New York, and the trial is expected to start in October 2016.
MRK closed Monday's trading at $57.26, up 0.74%.
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