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.
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.
Merck spinoff Organon on Friday said it "stands behind the safety and efficacy of Propecia," and is working with the FDA "to determine the best path forward." Representatives for the Post-Finasteride Syndrome Foundation could not immediately be reached. The FDA declined to comment.
Read also: Merck to stop Phase 3 KEYLYNK-010 trial investigating Combo therapy of KEYTRUDA and LYNPARZA
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.