New York AG Demands FDA Take Action On Concerns Over Popular Drug

NEW YORK — New York Attorney General Letitia James is demanding that the FDA take action on concerns over a popular allergy and asthma medication linked to harmful behavioral and mental health issues among children.

James called on the agency 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) highlighted recent reports of significant mental and behavioral health risks associated with Singulair use among children, including aggression, depression, and even suicide, and urged the 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," James said in a statement. "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."

James points out that Singulair has been on the market for 25 years, during which multiple studies have shown a correlation between Singulair usage and the development of neuropsychiatric disorders.

In March 2020, the FDA issued a "black box" warning for Singulair, citing mental and behavioral health risks associated with the use of the drug. So-called "black box" warnings are prominently displayed boxed warnings added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur. However, James says, reports of tragic adverse mental health events for pediatric patients, including aggression, depression, and suicide, remain prevalent.

Data recorded after the black box warning was issued suggest that the potential neuropsychiatric risks of Singulair are much greater for children than for adults, the AG said. Of the estimated 12 million people prescribed Singulair, approximately 1.6 million are children under the age of 18, according to data cited by James.

In her letter to the FDA commissioner, the AG's office noted a 2022 study that 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 the drug. Another recent study cited found that 62.4 percent of children with asthma between the ages of three and 18 reported neuropsychiatric events.

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 the FDA.

In her letter, she urged the FDA to prioritize providing more adequate warnings to the public about the potential adverse health effects of Singulair by taking direct and immediate 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.
• 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).

James said an alarming number of anecdotal reports submitted to the 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 experiences highlight the dangerous effects patients experience while taking Singulair, but they also show 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, according to the AG.

Patch reached out to Merck for comment, but the pharmaceutical company has not yet responded. An FDA spokesperson told the New York Times the agency would "respond directly to Ms. James."