MRK - FDA requires suicide warning on Organon's anti-baldness drug

The U.S. Food and Drug Administration (FDA) has for the first time required labeling changes to the popular anti-baldness pill Propecia marketed by Organon (NYSE:OGN) to reflect the risk of suicidal behavior in men taking the drug. Previously, the FDA has required labeling changes to the medication to flag risks of persistent sexual dysfunction and depression. In 2017, the patient advocacy group petitioned the agency citing several studies to order the then-developer of the drug Merck (MRK) to either stop selling it or require stricter warnings. However, the regulator said this week that the group's petition "does not provide reasonable evidence" of a causal link between the drug and persistent sexual issues, depression or suicide. Rejecting a request to pull the treatment from the market, the FDA said it is "requiring the addition of suicidal ideation and behavior" to the list of adverse reactions on its labeling. The Merck (MRK)

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FDA requires suicide warning on Organon’s anti-baldness drug