Agency approves label changes after reports of neuropsychiatric events

WASHINGTON — The FDA finalized and approved new safety labeling changes for prescription allergy and asthma drug montelukast (Singulair) after reports of severe mental health side effects prompted the agency to require a Boxed Warning on the drug.

“The agency is taking this action after a review of continued reports of neuropsychiatric events, feedback from stakeholders, and a re-evaluation of the benefit and risk profile of the drug,” the FDA explained. “Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. The label changes will provide a stronger warning of potential risks, so health care professionals and patients/caregivers can make informed decisions about use of the medication and look for warning signs.”

The Boxed Warning informs physicians and patients of the risk for severe neuropsychiatric effects, advising physicians to discuss these risks with patients, carefully monitor for any adverse events, and cease treatment immediately if any neuropsychiatric symptoms occur. It also advises physicians to reserve use of montelukast for patients with allergic rhinitis who have an inadequate response or intolerance to alternative drug options.

The decision to add the strengthened warning to montelukast, which the FDA announced in March 2020, was based on adverse event reports submitted to the agency, an observational study using data from the FDA’s Sentinel System, and a review of observational and animal studies on the drug. Reported side effects included depression, disorientation or confusion, hallucinations, memory problems, obsessive-compulsive disorder, and suicidal thoughts and actions leading to completed suicides, among others.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 100

Topic ID: 80,100,730,100,99,192,151,725