FDA Requires Boxed Warning for Commonly-Prescribed Asthma Medication


The FDA is now requiring a boxed warning for montelukast (Singulair) to strengthen the existing warning about the risk of neuropsychiatric events.

The FDA is now requiring a boxed warning for montelukast (Singulair) to strengthen the existing warning about the risk of neuropsychiatric events. The warning advises prescribers to avoid montelukast in patients with mild symptoms, especially those with allergic rhinitis.

Montelukast is approved to prevent asthma attacks and for long-term treatment of asthma in adults and children aged 1 year or older. It is also approved to prevent exercise-induced asthma in patients aged 6 years or older. For patients with seasonal outdoor allergies, montelukast is approved to help control nasal symptoms in patients aged 2 years or older, and to control year-round allergies in patients 6 months or older.

The warning comes after the FDA’s review of available data regarding continued reports of neuropsychiatric events, such as agitation, depression, sleeping problems, and suicidal thoughts and actions.

The administration reviewed the benefits and risks of montelukast since the drug was first approved in 1998 and determined that the risks may outweigh the benefits in some patients. For allergic rhinitis in particular, the FDA advises that montelukast should be reserved for patients who have not responded to other therapies or who cannot tolerate those therapies.

The product labeling was last updated in 2008 to include information about neuropsychiatric events associated with use of the drug. The new boxed warning is the FDA’s most prominent warning. The administration is also requiring a new patient medication guide to educate patients and caregivers about the medication.

“We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in a statement. “The incidence of neuropsychiatric events associated with montelukast is unknown, but some reports are serious, and many patients and health care professionals are not fully aware of these risks.”


FDA Requires Stronger Warning About Risk of Neuropsychiatric Events Associated with Asthma and Allergy Medication Singulair and Generic Montelukast [news release]. White Oak, MD; March 4, 2020. FDA website, https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warning-about-risk-neuropsychiatric-events-associated-asthma-and-allergy. Accessed March 5, 2020.

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