Merck's (MRK) asthma drug Singulair, now manufactured by Organon, a Merck spin-off, and generic versions of montelukast have been linked to serious mental health problems for some users in a US Food and Drug Administration study, Reuters reported Friday, citing a scientific presentation it reviewed.
The FDA has cautioned its studies of the drug are ongoing, and the results have not been finalized. But after years of analysis of the drug, the FDA added a 'black box' warning in 2020 to the drug's prescribing label, alerting users to serious mental health risks like suicidal thinking or actions, Reuters said. Reuters quoted the FDA as saying it does not plan to update the drug's label based on data from the latest presentation.
In the presentation, researchers said they found the drug, introduced in 1998 and prescribed and sold generically as montelukast, attaches to multiple brain receptors affecting psychiatric functioning, Reuters reported.
Merck did not immediately reply to MT Newswires' request for comment.
(Market Chatter news is derived from conversations with market professionals globally. This information is believed to be from reliable sources but may include rumor and speculation. Accuracy is not guaranteed.)
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