Montelukast Gets Boxed Warning for MH Effects

The Food and Drug Administration is now requiring a boxed warning for montelukast, which is sold both under the brand name Singular and in generic form to treat asthma and hay fever (allergic rhinitis). The boxed warning strengthens an existing warning about the risks of neuropsychiatric events with montelukast such as agitation, depression, sleep problems, and suicidal thoughts and actions. The warning advises health professionals to avoid prescribing montelukast for patients with mild symptoms, particularly those with hay fever.

The FDA required the box warning after reviewing multiple reports of suicide and other adverse events by patients taking the medication. This included reports submitted through the agency’s Adverse Event Reporting System (FAERS), and studies published in the medical literature. The FDA had also conducted its own study using data in the Sentinel Distributed Database, which is generated from patient interactions in the United States health care system through their insurers and providers. These findings were presented at an FDA advisory committee meeting in 2019.

“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,” the agency said in a March 4 Drug Safety Communication. ■