US FDA directs risk of suicide disclosure on Merck antibaldness pill Propecia
New Delhi: The U.S. health regulators, the USFDA rejected a request to remove popular anti-baldness pill Propecia and its generic versions from the market, but for the first time required patient notification about reports of suicidal behavior in men taking the drug.
The U.S. Food and Drug Administration has previously approved revised Propecia labels that mentioned risks of persistent sexual dysfunction and depression but not suicide. A patient advocacy group, the Post-Finasteride Syndrome Foundation, petitioned the FDA in 2017 to order Merck & Co to either stop selling the drug or require far stronger warnings, citing several scientific studies. Finasteride is the generic name for Propecia.
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