Boxed Warning Added To Montelukast Labeling

Washington, 1 May 2020:

The Food and Drug Administration (FDA) has approved the updated labeling for montelukast to include the addition of a Boxed Warning related to serious neuropsychiatric events. The action was taken following a review of study data and case reports related to neuropsychiatric adverse events reported in patients treated with montelukast.

Given the potential for neuropsychiatric events, the benefits and risks associated with montelukast treatment should be discussed with patients and caregivers prior to prescribing. For some, the benefits of treatment may not outweigh the risks, particularly in patients with mild disease that may be adequately controlled with alternative therapies.

Additionally, monitoring for these events is recommended, and in patients who develop neuropsychiatric symptoms, immediate discontinuation should be advised. In some cases, neuropsychiatric symptoms have persisted even after the treatment was halted, therefore monitoring should be continued until symptoms resolve.

Montelukast, a leukotriene receptor antagonist, is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients ≥12 months of age and for prevention of exercise-induced bronchoconstriction in patients ≥6 years of age. It is also approved for the relief of symptoms of seasonal allergic rhinitis in patients ≥2 years of age and perennial allergic rhinitis in patients ≥6 months of age, however, the new labeling advises that montelukast should be reserved only for allergic rhinitis in patients who have had an inadequate response or intolerance to alternative therapies. Monthly Prescribing Reference