We are recommending that montelukast should only be used for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies.
Ask patients about any history of psychiatric illness prior to initiating treatment.
Consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine.
Advise all patients of the risk of neuropsychiatric events when prescribing montelukast. Warnings about these side effects are included in the existing prescribing information; however, many health care professionals and patients/caregivers are not aware of this risk, and suicides and other adverse events continue to be reported.
Advise patients and parents/caregivers that the patient should stop taking montelukast and contact a health care professional immediately if changes in behavior or new neuropsychiatric symptoms, suicidal thoughts or behavior occur.
Monitor all patients treated with montelukast for neuropsychiatric symptoms. Events have occurred in patients with and without pre-existing psychiatric disease.Most reported cases of neuropsychiatric events occurred during montelukast treatment, but some occurred after discontinuation. In many cases, symptoms resolved after stopping montelukast; however, in some cases symptoms persisted after discontinuation from therapy or were reported after discontinuation of therapy.
Encourage patients and parents/caregivers to read the Medication Guide they receive with their montelukast prescriptions, which explains the safety risks and provides other important information.
To help FDA track safety issues with medicines, report adverse events involving montelukast or other medicines to the FDA MedWatch.
