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 current warnings about the drug’s psychiatric side effects 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 linked to the drug, which is also known generically 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.
However, an examination by the New York Times found that people continued to report being unaware of the potential side effects, which include 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 regulations for the drug,” particularly for children.
“Parents and guardians have the right to be fully informed about the potential side effects of a drug when making health choices for their children,” Ms. James said in a statement Thursday. “The risks associated with taking Singulair are too scary to occur 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 big success for Merck in its early years. Now generic, it’s still useful for doctors, especially since kids can take a chewable pill once a day instead of using 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 drug, according to data provided to The Times by Komodo Health, a medical data company.
Merck continued to defend the drug in court, but earlier referred the comment to a generic maker, Organon, which said the drug’s risks had been communicated to patients and health care providers.
Faced with criticism over the years about the drug’s continued availability despite the risks, the FDA said it 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, have not been possible.
Ms. James’ letter outlines more steps the FDA could take, including new drug safety communications to doctors, pharmacists and other health care providers. He urged further review to ensure the drug still offers more benefit than risk to children.
Thomas Moore, a long-time drug safety expert monitored reports on the psychiatric effects of montelukast, he said the FDA is known to push drug makers to conduct investigations to determine whether warnings are reaching patients.
“This underscores that all parents of children taking this drug should be alert to unexpected changes in their behavior and consider this as a possibility,” said Mr. Moore of the Johns Hopkins Center for Safety and Efficacy. Medicines.
Kammy Pany, manager of a Facebook group for people who say they have been affected by the drug, he said he was pleased to learn Ms James was seeking action and a deeper review. Her son, she believed, had suffered side effects in 2017. For her, comforting parents who find the group was a consuming task.
“It is about time,” said Mrs. Pany. “My goal one day is to not have to do it anymore.”