Reuters: Group Sues to Have Hair-Loss Drug Propecia Pulled from Market
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, added a warning in 2012 about sexual dysfunction and depression, leading to a wave of patient lawsuits. Despite these warnings, 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
Learn more about PFS & PSSD
What is Post-Finasteride Syndrome?
PFS (Post-Finasteride Syndrome) is a complex and life-altering condition caused by the drug Finasteride (also marketed as Propecia) and other 5ar inhibitors. It affects physical, mental, and sexual health, leaving patients to suffer without adequate support, recognition or treatment.
What is Post-SSRI Sexual Dysfunction?
PSSD (Post-SSRI Sexual Dysfunction) is a serious and debilitating condition associated with the use of selective serotonin reuptake inhibitors (SSRIs) and similar drugs. It affects mental, physical, and sexual well-being, leaving many patients to suffer without sufficient support, recognition, or effective treatment.