New York AG asks FDA to double down on warnings, discourage prescription for asthma drug

by Tara Suter - 02/22/24 7:20 PM ET

FILE - A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. Expedited drug approvals slowed in 2022, as the FDA's controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the agency’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (AP Photo/Manuel Balce Ceneta, File) — A sign in front of the Food and Drug Administration building is seen on Dec. 10, 2020, in Silver Spring, Md. (AP Photo/Manuel Balce Ceneta)

The New York attorney general’s office is asking the Food and Drug Administration (FDA) to double down on its warnings and discourage the use of an asthma drug.

“The New York Office of the Attorney General writes to encourage the FDA to address the dangers of montelukast, particularly to the most vulnerable population—minor children—and protect all patients from these heartbreaking, unintended side effects,” Darsana Srinivasan, chief of the Office of the Attorney General’s Health Care Bureau, wrote in a Thursday letter addressed to FDA Commissioner Robert Califf.

Srinivasan noted that it “has been nearly four years since” the FDA “strengthened existing warnings regarding the mental and behavioral health side effects of asthma and allergy drug montelukast (brand name Singulair) by imposing a black box warning, the strictest and most serious warning given to medications.”

Srinivasan said since the decision, “the prevalence of tragic adverse mental health events” like depression and suicide are still “widely reported and disproportionately so for pediatric patients.”

Srinivasan called the black box warning “insufficient” and implored the federal agency to “take immediate action to prevent further unnecessary health risk to patients in our State related to the use of montelukast” via measures like “issuing a new Drug Safety Communication stating that the FDA is evaluating the risks of using montelukast in children under the age of 18 for asthma and allergic rhinitis.”

“I welcome any information you may wish to provide on any actions you are planning related to evaluating montelukast and its use in minor patients,” Srinivasan continued. “I appreciate the FDA’s attention to this important matter.”

The Hill has reached out to Merck, the maker of Singulair, and the FDA for comment.

Tags asthma fda FDA Merck New York attorney General Robert Califf