Nih And Fda Examine Serious Side Effect That Su... May 2026

The FDA and NIH are investigating serious neuropsychiatric side effects linked to the asthma medication Singulair (montelukast), following reports that the drug impacts the brain, including risks of suicidal thinking and hallucinations. Recent findings indicate the drug accumulates in the nervous system, prompting ongoing regulatory review of its safety, as the agencies work to improve the reporting of serious adverse events, of which only a small fraction are typically reported. For more details, read the Reuters report on US FDA finds widely used asthma drug impacts the brain .

Adverse Drug Event Monitoring at the Food and ... - PMC - NIH