Montelukast must have boxed warning for neuropsychiatric events risk insists FDA

The U.S. Food and Drug Administration has issued instructions to manufacturers of montelukas to strengthen an existing warning about the risk of neuropsychiatric events associated with the drug, which is used to treat asthma and allergic rhinitis (hay fever). The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis.

Food and drug administration, announced that it is requiring a boxed warning for montelukast (sold under the brand name Singulair and in generic form)

As noted in a new Drug Safety Communication issued today, the warning follows the review of Food and drug administration of available data regarding continued reports of neuropsychiatric events with montelukast, such as agitation, depression, sleeping problems, and suicidal thoughts and actions. The Drug Safety Communication includes recommendations for health care professionals and patients and a summary of the data that led to these warnings.

Montelukast is a leukotriene-modifying agent that was first approved by the FDA on February 20, 1998, for the prophylaxis and long-term treatment of asthma in adults and in children aged 6 years or older. It is currently indicated for perennial allergic rhinitis in children as young as 6 months. It is also indicated for the prophylaxis and treatment of asthma, the prevention of exercise-induced bronchospasm, and relief of allergic rhinitis symptoms.

An estimated 2.3 million children and adolescents aged 0 to 16 years received prescriptions for montelukast during 2018, according to the FDA briefing document. The highest proportion of those were children aged 6 to 11 years, followed by patients aged 12 to 16 years, 2 to 5 years, and 0 to 1 year.

"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," said Sally Seymour, M.D., director of the Division of Pulmonary, Allergy and Rheumatology Products in the FDA's Center for Drug Evaluation and Research. "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."

The Food and drug administration 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 evaluated available data regarding the risk of neuropsychiatric events, including reports submitted through the FDA Adverse Event Reporting System (FAERS) and observational studies in the published literature. The FDA also conducted an observational study using data in the Sentinel Distributed DatabaseExternal Link Disclaimer and presented the findings at an FDA advisory committee meeting in 2019.

As part of its review, the FDA re-evaluated the benefits and risks of montelukast as the treatment landscape has evolved since the drug was first approved in 1998. Based upon this assessment, the FDA determined 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 has determined that montelukast should be reserved for patients who have not responded adequately to other therapies — or who cannot tolerate these therapies.

In addition to the boxed warning, the Food and drug administration is also requiring a new Medication Guide to be given to patients with each montelukast prescription.

Health care professionals and patients should report side effects from montelukast to the FDA's MedWatch program.

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