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FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis

FDA Drug Safety Podcast

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Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On March 4, 2020 FDA strengthened existing warnings about serious behavior and mood-related changes with montelukast (brand name Singulair), a prescription medicine for asthma and allergy.

We are taking this action after a review of available information that led us to reevaluate the benefits and risks of montelukast use. Prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals, patients and caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts. We are requiring a Boxed Warning, our most prominent warning, be added to the prescribing information to describe these serious mental health side effects. We are also requiring a new patient Medication Guide to educate patients about the medicine.

We reviewed case reports submitted to FDA, conducted an observational study using data from the FDA’s Sentinel System, and reviewed observational and animal studies in the published literature. Given the available information, we also reevaluated the benefits and risks of use of montelukast and determined it should not be the first-choice treatment for mild allergic rhinitis.

Health care professionals should consider the risks and benefits of montelukast when deciding to prescribe or continue patients on the medicine. Counsel all patients about mental health side effects and advise them to stop the medicine and contact a health care professional immediately if they develop any symptoms. Only prescribe montelukast for allergic rhinitis in patients who have an inadequate response or intolerance to alternative therapies and for patients with asthma, we recommend that health care professionals consider the benefits, and risks of mental health side effects, before prescribing montelukast.

We continue to receive reports of mental health side effects with montelukast use. A wide variety of mental health side effects have been reported, including completed suicides. Some occurred during montelukast treatment and resolved after stopping the medicine. Other reports indicated that mental health side effects developed or continued after stopping montelukast. 

Side effects involving montelukast should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete Data Summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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