FDA Adds Boxed Warning to Montelukast Over Mental Health Risks

Megan Brooks 

March 04, 2020

The US Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair; Merck and generics), which is used to treat asthma and allergy.

The agency will add a boxed warning to montelukast advising healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, according to a drug safety communication.

The FDA updated the product labeling in 2008 to include information about neuropsychiatric events reported with use of montelukast.

In response to continued reports of suicide and other adverse events, the FDA reviewed all available data and conducted an observational study. As part of its review, the FDA reevaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in 1998. 

Based on their findings, the FDA determined that the risks of montelukast may outweigh the benefits in some patients, particularly when the symptoms of the disease are mild and can be adequately treated with alternative therapies. 

For allergic rhinitis in particular, the FDA says montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies. 

"We recognize that millions of Americans suffer from asthma or allergies and rely on medication to treat these conditions. 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," Sally Seymour, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. With the new boxed warning, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions, she added. 

"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," Seymour said. 

In addition to the boxed warning, the FDA will also require a new medication guide to be given to patients with each montelukast prescription.

Healthcare professionals are encouraged to report side effects from montelukast to the FDA's MedWatch program

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