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NEW YORK – 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. 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.”

Singulair has been on the market for 25 years, throughout which multiple studies have shown a correlation between Singulair usage and the development of neuropsychiatric disorders. In March 2020, FDA issued a black box warning for Singulair, citing the documented mental and behavioral health risks associated with the use of the drug. Despite this, reports of tragic adverse mental health events for pediatric patients, including aggression, depression, and suicide, remain prevalent.

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.

An alarming number of anecdotal reports submitted to FDA highlight the harmful side effects experienced by children taking Singulair. Parents shared that their children were displaying abnormal and aggressive behavior, intense nightmares, anxiety, suicidal thoughts, and suicide. Not only do these testimonials highlight the dangerous effects patients experience while taking Singulair, but they also reveal that families were not properly informed of the risks associated with the medication by their health care providers, or that the warning labels on the medication were not sufficient. Attorney General James asserts that this lack of specific warning, restriction, or contraindication regarding dangerous and potentially deadly side effects for pediatric patients calls for immediate action by FDA.

In the letter, Attorney General James urges 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).

This matter was handled by the Health Care Bureau, led by Deputy Bureau Chief Leslieann Cachola and Bureau Chief Darsana Srinivasan. The Health Care Bureau is a part of the Division for Social Justice, which is led by Chief Deputy Attorney General Meghan Faux and overseen by First Deputy Attorney General Jennifer Levy.

  allergy, asthma, Attorney General Letitia James, drug