Reuters: Lawsuit Seeks to Pull Propecia from the Market
Reuters: the Post-Finasteride Syndrome Foundation and Public Citizen sued the FDA to have Propecia and its generics pulled from the US market.
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A patient advocacy group has filed a lawsuit seeking to pull Merck & Co’s hair loss drug Propecia and its generic versions from the market, citing evidence that it causes depression, erectile dysfunction, and, in some cases, suicide.
The Post-Finasteride Syndrome Foundation, represented by Public Citizen, filed the lawsuit on Wednesday in Washington, D.C., federal court. The group claims that the Food and Drug Administration (FDA) unlawfully failed to act on their 2017 petition to either remove the drug from the market or add a “black box” warning about the severe side effects.
Propecia, approved in 1997, had persistent sexual side effects added to its label in 2011 and 2012 — as adverse reactions rather than warnings — and a wave of patient lawsuits followed. Despite those label changes, the drug’s popularity has continued to grow, with over 2.4 million prescriptions written in the U.S. in 2020, more than double the number in 2015.
The lawsuit cites a recent Reuters report revealing that Merck and the FDA were aware of reports of suicidal thoughts in Propecia patients as early as 2011. The foundation argues that the FDA’s failure to act on this evidence is unlawful and highlights the need for urgent regulatory action.
Canadian and European regulators already require a warning about the risk of suicide and advise discontinuing treatment if a patient becomes depressed. The foundation is calling for similar measures in the U.S. to protect public health.
Read the full story on Reuters: Group Sues to Have Hair-Loss Drug Propecia Pulled from Market
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