FDA requires boxed warning for montelukast

The FDA has issued a drug safety communication stating that it now requires a boxed warning for montelukast to strengthen the agency’s existing warning about the risk for neuropsychiatric events such as suicidal thoughts or actions associated with the drug, which is used to treat asthma and allergy, according to an agency press release.

The boxed warning also advises against prescribing montelukast, which is sold under the brand name Singulair (Merck) and in generic form, for patients with mild symptoms, especially those with allergic rhinitis. Additionally, the agency is requiring that a new medication guide be given to patients with each montelukast prescription.

The FDA’s decision to require the boxed warning is based on the agency’s review of available data about continued reports of neuropsychiatric events including agitation, depression, sleeping problems, and suicidal thoughts and actions with use of montelukast.

“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 the release. “With today’s action, the FDA aims to make sure patients and medical providers have the information available to make informed treatment decisions. 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.”

Product labeling for montelukast was updated in 2008 to include information about neuropsychiatric events reported with use of montelukast. As reports of suicide and other adverse events continued, the FDA evaluated available data on the risk for neuropsychiatric events, including from reports submitted through the FDA Adverse Event Reporting System and published observational studies. The agency also conducted an observational study using data in the Sentinel Distributed Database and presented the findings at an FDA advisory committee meeting in 2019, according to the release.

After a reevaluation of the benefits and risks of montelukast within the context of the evolution of the treatment landscape since the drug’s approval in 1998, the FDA determined the risks of treatment outweigh the benefits in certain patients, particularly those with mild symptoms that can be adequately treated with alternative therapies. In the case of allergic rhinitis in particular, the release stated, the FDA has determined that montelukast should be reserved for patients who have not responded to or cannot tolerate other therapies.