New York asks FDA to address Singulair controversy

New York Attorney General Letitia James implored the FDA Feb. 22 to update Singulair's warning label after an uptick in pediatric mental health issues linked to the asthma and allergy drug. 

Reported side effects of Singulair (montekulast) include aggression, depression, suicidal thoughts and hallucinations, especially among children. In 2020, the FDA updated the drug's warning label and strengthened it two years later, but physicians are still writing millions of prescriptions. 

Twelve million Americans are prescribed the medication, including 1.6 million children. A recent study found that 62.4% of children with asthma who took montekulast reported neuropsychiatric events. 

The FDA says it is reviewing adverse events related to Singulair, but in a letter, Ms. James asked the agency to reeducate clinicians about the drug's potential risks and evaluate whether Singulair, which has been on the market for 25 years, outweigh the side effects.

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