NY AG Urges Stricter Asthma Drug Warnings Due to Children’s Mental Health Risks

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.”

Asked for comment, Chanapa Tantibanchachai, a spokeswoman for the F.D.A., said on Thursday that the agency would respond directly to Ms. James.

The medication was a blockbuster for Merck in its early years. Now a generic, it remains a go-to for doctors, especially because children can take a chewable pill once a day rather than juggle an inhaler. It is not a steroid, which has been cited as another reason it is considered an option for asthmatic patients.

In 2022, more than 12 million people filled a prescription for the medication, according to data provided to The Times by Komodo Health, a medical data company.

Merck has continued to defend the drug in court, but had earlier referred comment to a generic maker, Organon, which said risks of the drug had been communicated to patients and health providers.

Faced with criticism over the years about the drug’s continued availability despite the risks, the F.D.A. has said it acted appropriately in response to concerns about the medication. The agency says it continues to study and monitor the drug, but that studies large enough to pinpoint rare events linked to the drug, like suicide, were not feasible.

Ms. James’s letter outlines more steps the F.D.A. could take, including new drug safety communications to doctors, pharmacists and other health care providers. She urged further review to ensure the drug still offered more benefit than risk for children.

Thomas Moore, a drug-safety expert who has long tracked reports of montelukast’s psychiatric effects, said the F.D.A. has been known to prompt drug makers to conduct surveys to determine whether warnings are reaching patients.

“This underlines that all parents of children taking this drug should be alert to unexpected changes in behavior and consider this as one possibility,” said Mr. Moore of the Johns Hopkins Center for Drug Safety and Effectiveness.

Kammy Pany, an administrator of a Facebook group for people who say they have been affected by the drug, said she was glad to learn that Ms. James was seeking action and a deeper review. Her son, she believed, had suffered side effects in 2017. For her, consoling parents who find the group has been a consuming task.

“It’s about time,” Ms. Pany said. “My goal one day is to not have to do this anymore.”