FDA strengthens warning of risk of serious neuropsychiatric events associated with montelukast, and advises restricting use for allergic rhinitis
The Food and Drug Administration (FDA) has strengthened its warnings for montelukast (a leukotriene receptor antagonist) with regard to the risk of serious behavior- and mood-related changes. The FDA has taken this action after re-evaluating the risks and benefits of montelukast following a review of submitted case reports and published observational and animal studies, and carrying out an observational study of FDA safety data. For allergic rhinitis, the FDA have determined that montelukast should be reserved for those who are not treated effectively with, or cannot tolerate, other allergy medicines.
Warnings about the risk of neuropsychiatric events (including suicidal thoughts or actions) are already included in the prescribing information for montelukast, but many healthcare professionals and patients/caregivers are not aware of the risk.
Montelukast is indicated for the relief of symptoms of allergic rhinitis; the prevention and chronic treatment of asthma; and the acute prevention of exercise-induced bronchoconstriction.
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Inflammation of the paranasal sinuses lasting more than 12 weeks.
Diagnosis is initially clinical. Nasal endoscopy may show inflammation, purulent discharge, edema, or frank polyps.
Initial medical treatment includes nasal saline irrigation and topical intranasal corticosteroids. Oral antibiotics, oral corticosteroids, antihistamines, and leukotriene receptor antagonists may also be considered.
Computed tomography is needed if initial medical treatment fails.
Functional endoscopic sinus surgery is very effective for patients unresponsive to medical treatment.
Chronic sinusitis is inflammation of the paranasal sinuses lasting more than 12 weeks. Symptoms include facial pressure, rhinorrhea, postnasal drainage, congestion, and general malaise. Chronic sinusitis is divided into 2 groups, with and without polyps, which have slightly different treatment regimens. This topic discusses chronic sinusitis in the absence of polyps. There is a separate topic covering nasal polyps.
History and exam
- ciliary dysfunction
- aspirin sensitivity
- allergic rhinitis
- airway hyperreactivity/asthma
- previous sinus surgery
- severe mid-septal deviations
- concha bullosa deformity
- paradoxically bent middle turbinates
- foreign bodies
- craniofacial anomalies
- granulomatosis with polyangiitis
- history of asthma
Section Head of Rhinology, Sinus, and Skull Base Surgery
Head and Neck Institute
Cleveland Clinic Foundation
RS is an author of a number of references cited in this topic.
Rhinology and Endoscopic Skull Base Surgery
Section of Otolaryngology - Head and Neck Surgery
Department of Surgery
University of Chicago Medicine & Biological Sciences
CR declares that he has no competing interests.
Dr R Sindwani and Dr C Roxbury would like to acknowledge Dr J Antisdel, a previous contributor to this topic.
James H. Quillen College of Medicine
East Tennessee State University
RPB declares that he has no competing interests.
Assistant Professor of Otolaryngology - Head and Neck Surgery
St Louis University School of Medicine
TS declares that he has no competing interests.
Istanbul Training and Research Hospital
OY declares that he has no competing interests.
Academic Medical Center
CG declares that he has no competing interests.
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