FDA Adds Boxed Warning to Montelukast Over Mental Health Ris
The US Food and Drug Administration (FDA) is strengthening existing warnings about serious behavior and mood-related changes with montelukast, which is used to treat asthma and allergy in adults and children 1 year and older. It is under the brand name Singulair and as generics which is available as tablets, chewable tablets, and oral granules.

The agency will add a boxed warning to montelukast advising healthcare providers to avoid prescribing montelukast for patients with mild symptoms, particularly those with allergic rhinitis, according to drug safety communication.

Health Professionals should ---

- 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 medicine.
-Advise all patients of the risk of neuropsychiatric events when prescribing montelukast.
-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.
-Encourage patients and parents/caregivers to read the Medication Guide they receive with their montelukast prescriptions.

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.

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information
Source: https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use
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