The A.G., Letitia James, called on the F.D.A. to redouble efforts to alert doctors about potential side effects of Singulair and to consider discouraging use of the drug in children.The New York attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew alerts to doctors and patients about the dangerous effects of Singulair for children, saying that the current warnings about the drug’s psychiatric side effects were not sufficient.In a letter, the attorney general, Letitia James, also called on the federal agency to consider discouraging the prescription of Singulair, an asthma and allergy drug, to children.Thousands of patients and parents have complained to the F.D.A. about symptoms of anxiety, rage, hallucinations and other psychiatric problems that they linked to the drug, which is also known in its generic form as montelukast. Those reports, combined with an emotional F.D.A. hearing in 2019 and cases cited in medical literature, led the F.D.A. in 2020 to order its most stringent warning on instructions for the drug’s usage.But an examination by The New York Times found that people continued to report that they were not aware of the possible side effects, which include suicide or suicide attempts, when they took the medication or gave it to their children.Ms. James cited The Times’s article, and called on the F.D.A. “to implement new, more stringent safety regulations for the drug,” particularly for children.“Parents and guardians have the right to be fully informed of a medication’s potential side effects when making choices about their children’s health,” Ms. James said in a statement on Thursday. “The risks associated with taking Singulair are far too dire to come without a very clear warning.”We are having trouble retrieving the article content.Please enable JavaScript in your browser settings.Thank you for your patience while we verify access. If you are in Reader mode please exit and log into your Times account, or subscribe for all of The Times.Thank you for your patience while we verify access.Already a subscriber? Log in.Want all of The Times? Subscribe.

In early 2020, the Food and Drug Administration responded to decades of escalating concerns about a commonly prescribed drug for asthma and allergies by deploying one of its most potent tools: a stark warning on the drug’s label that it could cause aggression, agitation and even suicidal thoughts.The agency’s label, which was primarily aimed at doctors, was supposed to sound an alert about the 25-year-old medication, Singulair, also known by its generic name, montelukast. But it barely dented use: The drug was still prescribed to 12 million people in the United States in 2022.Children face the greatest risks of the drug’s ill effects, and while usage by minors did decline, it was still taken by 1.6 million of them — including Nicole Sims’s son. Ms. Sims had no idea why, at 6, her son started having nightmares and hallucinations of a woman in the window. When he told her that he wanted to die, Ms. Sims went online, desperate for answers.Only then did she learn about the F.D.A. warning. She also found a Facebook support group with 20,000 members for people who had experienced side effects of the drug. Members of the group recounted a haunting toll that they linked to the drug with the help of peers, not their doctors.Singulair’s Boxed WarningThe Food and Drug Administration added a boxed warning to Singulair in 2020.