Montelukast (Singulair) Warning – FDA

The U.S. Food and Drug Administration (FDA) announced that it is requiring a boxed warning for montelukast (Singulair) due to the risk of neuropsychiatric events, such as agitation, depression, sleeping problems and suicidal thought and actions. The actual incidence of neuropsychiatric events associated with montelukast is unknown. As with any drug, the risks vs the benefits should be weighed when taking it.

Montelukast (Singulair) is FDA-approved for asthma and allergies. It is a prescription medicine approved to prevent asthma attacks and for the long-term treatment of asthma in adults and children 1 year and older. It is approved to prevent exercise-induced asthma in patients 6 years and older. Montelukast is also approved to control the symptoms of allergic rhinitis, also known as hay fever, such as sneezing, stuffy nose, runny nose, and itching of the nose. It is used to treat seasonal outdoor allergies in patients 2 years and older, and year-round indoor allergies in patients 6 months and older.

If you are on montelukast (Singulair) and have had any changes in behavior or mood or developed new neuropsychiatric symptoms, be sure to contact your healthcare provider so that you can be changed to a different medication. On the other hand, if you are taking montelukast and it has been helpful for your symptoms and you have had no behavior or mood changes but are concerned about taking it, you should speak to your healthcare provider first before making a decision to stop this medication.

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