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AG James Seeks to Protect Kids from Allergy Drug


New York Attorney General Letitia James called on the U.S. Food and Drug Administration (FDA) to take urgent action to address the potential dangers of the asthma and allergy drug montekulast, known by the brand name Singulair. According to AG James, Singulair has been linked to harmful behavioral and mental health issues among children who use the drug to treat asthma and respiratory allergies. In a letter to FDA Commissioner Robert M. Califf, the Office of the Attorney General (OAG) highlights recent reports of significant mental and behavioral health risks associated with Singulair use among minors, including aggression, depression, and even suicide, and urges FDA to implement new, more stringent safety regulations for the drug.

“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,” said Attorney General James. “The risks associated with taking Singulair are far too dire to come without a very clear warning. I am grateful to our partners at the U.S. Food and Drug Administration for the steps taken thus far to protect our most vulnerable from these dangerous side effects, and I urge the agency to adopt more stringent, clear warnings that reflect recent research.”

In statistics provided by the Attorney General’s Office, data recorded following the issuance of the black box warning suggest that the potential neuropsychiatric risks of Singulair are much greater for children than for adults. Of the estimated 12 million people prescribed Singulair, approximately 1.6 million are children under the age of 18. A 2022 study found that patients prescribed Singulair experienced higher rates of generalized anxiety disorder, insomnia, and prescriptions for antidepressants in the year after they began taking the medication as compared to those who were not taking Singulair. Another recent study found that 62.4 percent of children with asthma between the ages of three and 18 reported neuropsychiatric events.

In the letter, Attorney General James urges the FDA to prioritize providing more adequate warnings to the public about the potential adverse health effects of Singulair by taking the following actions:

  • Issuing a new Drug Safety Communication stating that the FDA is evaluating the risks of using Singulair in children under the age of 18 for asthma and allergic rhinitis;
  • Sending a Dear Health Care Provider letter to physicians, pharmacists, and other health care providers regarding Singulair’s safety risks to minors and urging providers to consider other FDA-approved medications for asthma or allergic rhinitis in children under the age of 18 years;
  • Conducting a review of all available information to determine whether the risk from use of Singulair clearly outweighs any therapeutic benefit in children and warrants a contraindication warning that it should not be used in children under 18; and
  • Evaluating whether any other interventions may be necessary to ensure that the potential benefits of Singulair use in children for the treatment of both asthma and allergic rhinitis outweigh the risks, such as requiring the imposition of risk evaluation and mitigation strategies (REMS).
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