New York Attorney General Letitia James is urging the FDA to do more to investigate the side effects of montelukast.
The FDA has warned that the asthma and allergy drug, sold under the brand name Singulair, could have psychiatric side effects. The agency added a boxed warning to montelukast's label in 2020 that the drug could cause "severe neuropsychiatric side effects," including agitation, aggression, depression and suicidal thoughts or behaviors.
In a Feb. 22 news release, the attorney general's office said data reported since the agency issued its 2020 warning indicates the psychiatric side effects are more severe among children.
In a letter to the agency, Ms. James urged the agency to issue a letter to providers warning them of the side effects of montelukast for children and encouraging them to use other treatments for asthma. Ms. James also asked the agency to reevaluate the drug and consider issuing a contraindication for the drug for those 18 and under.
"The risks associated with taking Singulair are far too dire to come without a very clear warning," Ms. James said in the news release. "I am grateful to our partners at the U.S. Food and Drug Administration for the steps taken thus far to protect our most vulnerable from these dangerous side effects, and I urge the agency to adopt more stringent, clear warnings that reflect recent research."
An FDA spokesperson told The New York Times Feb. 22 that the agency will respond to Ms. James directly.