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Montelukast Warning Upgraded

WASHINGTON — Concerned about “continued reports of suicide” and other neuropsychiatric events among users of the allergy and asthma drug montelukast (Singulair), the FDA is moving previous warnings about these risks into a black box, the agency said Wednesday.

“The boxed warning advises health care providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis,” according to the FDA’s news release.

It noted that the drug’s label has included warnings about these events since 2008, but displayed less prominently.

Data accumulated since then prompted the upgrade, the agency said; these were reviewed in a separate safety communication posted Wednesday. Analysis of the FDA’s ADVERSE Event Reporting System from 1998 (when the drug was first approved) to 2019 identified 82 cases of completed suicide in patients using the drug. In 64 of these for which the patient’s age was known, 19 were in children and teens younger than 18.

Yet data from the FDA’s Sentinel System from 2010 to 2015 did not support increased risks of psychiatric events when use of montelukast was compared to inhaled corticosteroids. Among some 450,000 asthma patients older than 6, there were no significant increases in risks for inpatient depressive disorder or self-harm. The analysis also showed decreased risk for treated outpatient depressive disorder with montelukast versus inhaled steroids (HR 0.91, 95% CI 0.89-0.93). The Sentinel study did have a number of limitations, however.

Still, the anecdotal reports plus animal studies indicating that montelukast crosses the blood-brain barrier persuaded the FDA that a stronger warning is needed.

“Due to the wide availability of alternative safe and effective allergy medicines with long histories of safety, we have reevaluated the risks and benefits of montelukast and have determined it should not be the first choice treatment particularly when allergic rhinitis symptoms are mild,” the agency stated. “In addition, many health care professionals and patients/caregivers are not aware of the risk of mental health side effects despite the existing warnings in the prescribing information.” The agency is also requiring manufacturers to provide new patient medication guides.

Montelukast should be used in allergic rhinitis only for patients not responding or intolerant to alternative treatments such as over-the-counter medications, the FDA reiterated. All patients prescribed the drug should be counseled on the risks and urged to report any new neurologic or psychiatric symptoms that may develop.