ALBANY- Attorney General Letitia James called on the U.S. Food and Drug Administration (FDA) earlier this week to take urgent action to address the potential dangers of the asthma and allergy drug Montekulast, known by the brand name Singulair. According to James, Singulair has been linked to harmful behavior and mental health issues in children who use the drug.
“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,” said James. “The risks associated with taking Singulair are far too dire to come without a very clear warning.”
In a letter to FDA Commissioner, James sited reports of mental and behavioral health risks associated with Singulair use among minors and recommended new, more stringent safety regulations for the drug.
Singulair has been on the market for 25 years, and James says during that time multiple studies have shown a correlation between Singulair usage and the development of neuropsychiatric disorders including reports of tragic adverse mental health events for pediatric patients, including aggression, depression, and suicide.
James says the FDA should issue a new Drug Safety Communication stating that the FDA is evaluating the risks of using Singulair in children under the age of 18. She also called for the FDA to consider approving other medications for children under the age of 18.
“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,” said James.
