FDA Strengthens Boxed Warning for Singulair (Montelukast) and Its Generics Due to Mental Health Risks.

 FDA Strengthens Boxed Warning for Singulair (Montelukast) and Its Generics Due to Mental Health Risks



Posted by : Bismoy Ghosh 

Target Audience: Patients, Health Professionals, Pharmacists, Allergy and Immunology Experts



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Issue Summary:


The U.S. Food and Drug Administration (FDA) has strengthened existing warnings about serious behavior and mood-related changes with montelukast (brand name: Singulair, and its generics). This prescription medicine is commonly used to treat asthma and allergies.


Although prior warnings existed, the FDA found that many healthcare professionals and patients/caregivers were unaware of the risks. After an extensive review and consultation with external experts, the FDA determined that a Boxed Warning—its strongest safety warning—was necessary.



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What is Montelukast?


Montelukast is an FDA-approved medication for:


Preventing asthma attacks and managing long-term asthma in patients aged 1 year and older


Preventing exercise-induced asthma in patients aged 6 years and older


Treating symptoms of allergic rhinitis (hay fever), including sneezing, runny or stuffy nose, and nasal itching


Seasonal allergies: For patients 2 years and older


Year-round allergies: For patients 6 months and older





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Boxed Warning:


Risks Include:


Suicidal thoughts or behaviors


Agitation, aggression, depression


Sleep disturbances, hallucinations


Other serious neuropsychiatric symptoms



These risks can occur with or without a previous history of mental illness.



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Recommendations for Patients:


Discuss benefits and risks of montelukast with your doctor.


Inform your doctor about any history of mental health issues.


Stop taking the medication and contact a healthcare provider immediately if behavior changes, suicidal thoughts, or unusual symptoms occur.




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Recommendations for Healthcare Providers:


Screen for psychiatric history before prescribing.


Discuss the neuropsychiatric risks clearly with all patients and caregivers.


Monitor patients regularly for any behavioral changes.


Encourage patients to read the Medication Guide that comes with prescriptions.




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Report Side Effects to FDA:


Adverse events or side effects can be reported to the FDA’s MedWatch Safety Program:

Submit online: MedWatch Online Reporting

Or call: 1-800-332-1088 to request a form and submit by mail or fax (1-800-FDA-0178)



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Source:
Official FDA Announcement – Montelukast Boxed Warning

Submit online: MedWatch Online Reporting


Or call: 1-800-332-1088 to request a form and submit by mail or fax 

(1-800-FDA-0178)




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Source:

Official FDA Announcement – Montelukast Boxed Warning

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