FDA Adds Boxed Warning to Montelukast Label


The label update comes after findings have repeatedly shown an associated risk of neuropsychiatric events.


The US Food and Drug Administration (FDA) is now requiring montelukast (Singulair) and its generic forms carry a boxed warning for its associated risks of neuropsychiatric events when used to treat asthma and allergic rhinitis.

The boxed warning, the FDA’s most prominent warning, advises physicians avoid prescribing the therapy for patients with mild symptoms—particularly patients with allergic rhinitis. Montelukast’s product labeling was previously updated in 2008 to include information regarding the prevalence of neuropsychiatric events.

The warning follows the administration’s review of available Montelukast clinical data which showed continued reports of neuropsychiatric events in treated patients, including agitation, depression, sleeping problems, and suicidal thoughts and actions.

Data were received through the FDA Adverse Events Reporting System (FAERS), published observational studies, and the Sentinel Distributed Database External Link Disclaimer, as well as a presentation of findings in an FDA advisory committee meeting last year. Based on their assessment, they ruled the risks of the drug may outweigh its benefits in some patients—particularly among those with mild symptoms adequately treated with alternative therapies.

Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’S Center for Drug Evaluation and Research, noted the incidence of neuropsychiatric events associated with the longtime therapy is unknown. That said, the findings are serious enough to warrant the risks.

“With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions,” Seymour said. “Importantly, there are many other safe and effective medications to treat allergies with extensive history of use and safety, such that many products are available over the counter without a prescription.”

Montelukast was first approved by the FDA in 1998.

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