Albany, New York – The New York attorney general’s office is urging the Food and Drug Administration (FDA) to take stronger actions against the use of an asthma drug known as montelukast, more commonly referred to as Singulair, due to concerns about its potential side effects, particularly in children.
The Office of the Attorney General’s Health Care Bureau chief, Darsana Srinivasan, raised concerns in a letter to FDA Commissioner Robert Califf about the existing warnings for montelukast, emphasizing the need to protect the most vulnerable population, especially minor children, from the drug’s unintended side effects. It has been reported that since the FDA imposed a black box warning, the strictest warning given to medications, regarding the mental and behavioral health side effects of montelukast, there has been a continued prevalence of tragic adverse mental health events, particularly affecting pediatric patients.
Srinivasan deemed the black box warning as insufficient and urged the FDA to take immediate action to prevent further unnecessary health risks, especially in minor patients, by evaluating the risks associated with using montelukast in children under the age of 18 for asthma and allergic rhinitis. The letter also invited the FDA to provide any information regarding actions being planned related to the evaluation of montelukast’s use in minor patients.
The attorney general’s office is calling for a new Drug Safety Communication from the FDA, specifically addressing the risks of using montelukast in children, and is seeking stronger measures to protect patients in New York from the potential dangers associated with the drug. The involvement of the FDA and the drug manufacturer, Merck, is being sought for comments on the matter.
The potential risks associated with the use of montelukast in pediatric patients and the continued prevalence of adverse mental health events remain of significant concern, prompting the attorney general’s office to push for additional actions from the FDA to address these issues.