The popular allergy and asthma medication commonly prescribed for children, montelukast– marketed under the brand name Singulair– may be leading to dangerous physical and mental dangers.
Now New York Attorney General Letitia James is demanding that the FDA take action.
In a letter to FDA Commissioner Robert M. Califf, the Office of the Attorney General (OAG) highlighted recent reports of significant mental and behavioral health risks associated with Singulair use among children. Anecdotal evidence provided by parents of children taking the medication say that they were displaying abnormal and aggressive behavior, intense nightmares, anxiety, suicidal thoughts and suicide.
“Parents and guardians have the right to be fully informed of a medication’s potential side effects when making choices about their children’s health,” James said in a statement. “The risks associated with taking Singulair are far too dire to come without a very clear warning. 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.”
James points out that Singulair has been on the market for 25 years, during which multiple studies have shown a correlation between Singulair usage and the development of neuropsychiatric disorders.
In March 2020, the FDA issued a “black box” warning for Singulair, citing mental and behavioral health risks associated with the use of the drug. “Black box” warnings are prominently displayed warnings added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur. However, despite the serious warning, reports of grave adverse mental health events for pediatric patients, including aggression, depression, and suicide, remain widespread.
According to James, the potential neuropsychiatric risks of Singulair are even greater for children than for adults. Of the estimated 12 million people prescribed Singulair, approximately 1.6 million are children under the age of 18, according to data cited by the AG.
A 2022 study that found that patients prescribed Singulair experienced higher rates of generalized anxiety disorder, insomnia, and prescriptions for antidepressants in the year after they began taking the medication as compared to those who were not taking the drug. Another recent study cited found that 62.4 percent of children with asthma between the ages of three and 18 reported neuropsychiatric events.
In the letter James calls for immediate action by the FDA. Among these actions, to send a “Dear Health Care Provider” letter to physicians, pharmacists, and other healthcare providers regarding Singulair’s safety risks to minors and urging providers to consider other FDA-approved medications for asthma or allergic rhinitis in children under the age of 18 years and conducting a review of all available information to risk against benefits.
