NY AG Requests FDA Review Safety Labeling on Singulair

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The New York State Office of the Attorney General is asking FDA to add more safety labeling to asthma medication Singulair.

In a letter addressed to FDA commissioner Robert M. Califf, M.D., Darsana Srinivasan writes that it has been four years since the regulatory agency strengthened existing warnings against Singulair.¹ According to the letter, the medication has been linked to aggression, depression, and suicide. In March 2020, FDA issued a black box warning on the medication, but the NY AG’s letter says that the side effects are ongoing and stronger warnings should be placed on the medication since the side effects appear to be more common in pediatric patients.

Srinivasan is chief of the health care bureau in the NY AG’s office.

The letter includes multiple anecdotal reports that have been submitted to FDA since March 2020, including on parent describing their 14-year-old’s reaction to the medication. They said, “neuropsychic and physical symptoms slowly worsened [while on montelukast]… She spent increasing amounts of time in my bed due to nightmares, she became fearful that she would be murdered in her bed and she took to sleeping with a knife under her pillow.”

Another parent reported, “[f]or an entire year, my family was on suicide watch for a 10-year-old boy who screamed daily in fits of anger, sadness, and depression ‘I want to die,’ ‘just kill me,’ ‘I’m so stupid and I don’t want to live anymore,’ and ‘my brain is telling me I’m dumb and I don’t deserve to live.’ Kicking. Hitting. Screaming. Hiding under covers in fits of tears.”

The black box warning is one of FDA’s strictest warnings that it can place on a medication. The potential side effects are listed on a large black box on the medication’s packaging, and health care providers must provide educational materials to patients when they are prescribed the drug. The medication is still FDA approved for children at least 1 year old and up for the treatment of asthma. It is also approved for the treatment of allergies for children as young as six months.

According to the letter, instances of serious side effects are still reported in relation to the drug. It requests that FDA consider several actions. These include issuing a new Drug Safety Communication, sending a Dear Health Care Provider letter to physicians, pharmacists, and other HCPs, reviewing all available information to determine if the risks of the drug outweigh the benefits, and determining if other interventions are required.

Source

1. Srinivasan, Darsana. Letter to Honorable Robert M. Califf, M.D., Commissioner. State of New York Office of Attorney General. February 21, 2024. Accessed February 27, 2024. https://ag.ny.gov/sites/default/files/letters/fda-letter-re-singulair.pdf