New York Attorney General Urges Stricter Warnings on Asthma Medications Due to Mental Health Risks for Children

New York’s 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 on children, saying that current warnings about psychiatric side effects of the drug were not enough.

In a letterAttorney General Letitia James also asked the federal agency to consider discouraging the prescribing of Singulair, an asthma and allergy medication, to children.

Thousands of patients and parents have complained to the FDA about symptoms of anxiety, rage, hallucinations and other psychiatric problems they linked to the drug, which is also known in its generic form as montelukast. Those reports, combined with an emotional FDA hearing in 2019 and cases cited in the medical literature, led the FDA in 2020 to order its strictest warning on the drug’s instructions for use.

But an examination by The New York Times found that people continued to report that they were unaware of possible side effects, including suicide or suicide attempts, when taking the drug or giving it to their children.

Ms. James cited the Times article and called on the FDA “to implement new, stricter safety standards for the drug,” particularly for children.

“Parents and guardians have the right to be fully informed about the possible side effects of a medication when making decisions about their children’s health,” Ms. James said in a statement Thursday. “The risks associated with taking Singulair are too serious to be presented without a very clear warning.”

When asked for comment, FDA spokesperson Chanapa Tantibanchachai said Thursday that the agency would respond directly to Ms. James.

The drug was a blockbuster for Merck in its early years. Now a generic, it remains an option for doctors, especially since children can take a chewable pill once a day instead of juggling an inhaler. It is not a steroid, which has been cited as another reason why it is considered an option for asthmatic patients.

In 2022, more than 12 million people filled a prescription for the drug, 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 previously referred its comments to a generic maker, Organon, which said the drug’s risks had been communicated to patients and health care providers.

Facing criticism over the years about the drug’s continued availability despite risks, the FDA has said it acted appropriately in response to concerns about the drug. The agency says it continues to study and monitor the drug, but studies large enough to identify rare drug-related events, such as suicide, were not feasible.

Ms. James’ letter outlines more steps the FDA could take, including new communications about drug safety to doctors, pharmacists and other health care providers. She urged more reviews to ensure the drug still offered more benefits than risks for children.

Thomas Moore, a long-time drug safety expert tracked reports of montelukast’s psychiatric effects, he said the FDA is known to urge drugmakers to conduct surveys to determine whether warnings are reaching patients.

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

Kammy Pany, administrator of a facebook group for people who say they have been affected by the drug, she said she was pleased to hear that Ms James was seeking action and a further review. She believed her son had suffered side effects in 2017. For her, comforting parents who find the group has been an exhausting task.

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