FDA requires disclosure of suicide risk for anti-baldness drug

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Brain food
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FDA requires disclosure of suicide risk for anti-baldness drug

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The FDA finally responded to the request of the Post-Finasteride Syndrome Foundation but the agency still refuses to recognize that there is proof that it can cause permanent sexual dysfunction. They are requiring a stronger warning but it is still relatively weak.

“U.S. health regulators 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 (MRK.N) to either stop selling the drug or require far stronger warnings, citing several scientific studies. Finasteride is the generic name for Propecia.

In a response this week, the FDA said the group's petition "does not provide reasonable evidence" of a causal link between Propecia and persistent sexual problems, depression or suicide. However, based on patient reports, the FDA said it is "requiring the addition of suicidal ideation and behavior" to the adverse reactions listed on Propecia's label.”

https://www.reuters.com/business/health ... 022-06-10/
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