New York’s attorney general is pushing for stricter warnings for asthma medications

New York’s attorney general on Thursday urged the Food and Drug Administration to “take immediate action” and renew warnings to doctors and patients about Singulair’s dangerous effects on children, saying the current warnings about the psychiatric side effects of the drug were not sufficient.

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

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

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

Ms. James quoted The Times article and called on the FDA “to implement new, stricter safety regulations for the drug,” especially for children.

“Parents and guardians have the right to be fully informed about the potential side effects of a medicine when making choices about the health of their children,” Ms James said in a statement on Thursday. “The risks associated with using Singulair are far too great to happen without a very clear warning.”

Asked for comment, Chanapa Tantibanchachai, an FDA spokeswoman, said Thursday that the agency would respond directly to Ms. James.

The drug was a blockbuster for Merck in its early years. It is now a generic drug and remains a favorite for doctors, especially because children can take a chewable tablet once a day instead of having to juggle an inhaler. It is not a steroid, which is cited as another reason why it is considered an option for asthmatics.

More than 12 million people filled a prescription for the medication in 2022, 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 comment 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 its risks, the FDA has said it has acted appropriately in response to concerns about the drug. The agency says it continues to study and monitor the drug, but that studies large enough to detect rare events linked to the drug, such as suicide, were not feasible.

Ms. James’ letter outlines more steps the FDA could take, including new drug safety communications to doctors, pharmacists and other health care providers. She urged further evaluation to ensure the drug still provides more benefit than risk for children.

Thomas Moore, a long-time drug safety expert tracked reports of montelukast’s psychiatric effects, said the FDA is known to push drugmakers to conduct studies 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 a 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 pleased to hear Ms James was seeking action and a deeper investigation. Her son, she believed, suffered from side effects in 2017. For her, comforting parents who find the group has been a time-consuming task.

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