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https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-widely-used-asthma-drug-impacts-brain-2024-11-22/
>>summary: Singulair binds to brain receptors affecting psychiatric functionsMerck spinoff Organon confident in Singulair's safety profileFDA has no plan to update drug label based on new data
>Nov 22 (Reuters) - U.S. government researchers have found that a widely prescribed asthma drug originally sold by Merck & Co (MRK.N), opens new tab may be linked to serious mental health problems for some patients, according to a scientific presentation reviewed by Reuters.
The researchers found that the drug, sold under the brand name Singulair and generically as montelukast, attaches to multiple brain receptors critical to psychiatric functioning.
Singulair was a blockbuster product for Merck after its launch in 1998, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so benign that they were "similar to a sugar pill," while the label said any distribution in the brain was "minimal." Generic versions are still prescribed to millions of adults and children every year.
But by 2019, thousands of reports of neuropsychiatric episodes, including dozens of suicides, in patients prescribed the drug had piled up on internet forums and in the U.S. Food and Drug Administration’s tracking system. Such “adverse event” reports do not prove a causal link between a medicine and a side effect, but are used by the FDA to determine whether more study of a drug’s risks are warranted.
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