US FDA strengthens warning of risk of serious neuropsychiatric events associated with montelukast, and advises restricting use for allergic rhinitis
The US 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 reevaluating 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 has 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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Presumptive diagnosis of allergic rhinitis may be made in the presence of nasal congestion, sneezing, and itchy nose/palate/eyes with a pattern of allergic triggers.
Definitive diagnosis would require specific IgE reactivity during skin-prick or in vitro testing, but a trial of therapy may be ordered on the basis of a presumptive clinical diagnosis.
Treatment consists of allergen avoidance where possible and pharmacotherapy (antihistamines, corticosteroids, cromolyn, decongestants, leukotriene receptor antagonists). Immunotherapy is often an option in patients with persistent symptoms.
Reducing exposure to environmental allergens (e.g., dander, dust mite, and pollen) is an important measure for patients who are sensitive to these items, and can often be recommended empirically based on the patient's history.
Intranasal corticosteroids remain the single most effective class of medications for treating allergic rhinitis.
Allergic rhinitis (AR) is a common yet under-appreciated inflammatory condition of the upper respiratory tract, characterized by nasal pruritus, sneezing, rhinorrhea, and nasal congestion, the last of which is often deemed the most bothersome symptom. Frequently, there is associated palate, throat, ear, and eye itching as well as eye redness, puffiness, and watery discharge. AR is most often mediated by an IgE-associated response to ubiquitous indoor and/or outdoor environmental allergens, but is sometimes due to occupational or hobby exposures to proteins that do not commonly provoke IgE-mediated responses. Examples include woodworkers becoming sensitized to wood dusts, or food service workers becoming sensitized to grain dusts.
History and exam
- palate, throat, ear, and eye itching
- eye redness, puffiness, and watery discharge
- fatigue and irritability
- nasal congestion
- allergic shiners
- conjunctival injection
- ocular mucoid discharge
- nasal crease
- pale nasal mucosa
- swelling of the nasal mucosa and turbinates
- abundant clear nasal secretions
- Dennie-Morgan lines (creases present under the lower eyelids)
- family history of atopy
- age <20 years
- positive allergen skin-prick tests
- inadequate exposure to animals and other microorganism-rich environments in early life
- Western lifestyle
- environmental pollution
- exposure to indoor allergens such as animal dander and dust mites
- heavy maternal smoking (20 or more cigarettes/day during the first year of life)
- early introduction of foods or formula
- presence of other atopic conditions (eczema, food allergies, wheezing/asthma)
American College of Allergy, Asthma & Immunology
American Academy of Allergy, Asthma & Immunology Registry
Assistant Clinical Professor of Medicine
Medical College of Wisconsin
Adjunct Clinical Instructor
College of Nursing
University of Wisconsin-Milwaukee
Fight Asthma Milwaukee Allies
Allergy, Asthma & Sinus Center
GCS has taken part in sponsored research for the ALK clinical trial of the house dust mite SLIT tablet for use in pediatric patients. He is a member of the Joint Task Force on Practice Parameters Workgroup on the Allergic Rhinitis Practice Parameter.
Dr Gary C. Steven would like to gratefully acknowledge Dr Alexander Greiner, a previous contributor to this topic.
AG has received grant/research support from: Astra Zeneca; Boehringer Ingelheim; Cephalon Circassia Ltd; Clement Clarke Cytos biotechnology; GlaxoSmithKline; Glenmark Specialty, S.A.; Hoffman-LaRoche/Genentech; HRA/Novartis; Janssen Research & Development; Kalypsys , Inc.; Lupin; Merck; Mylan Pharmaceuticals, Inc.; Nestle (Nestec Ltd); Novartis Ono Pharmaceutical Co., Ltd.; Perrigo; Rigel Pharmaceuticals, Inc.; Roxane Laboratories Inc.; Shionogi Inc.; Sunovion TEVA Branded Pharmaceutical Products; UBC (United Biosource Corporation)/Amgen Pharmaceuticals; and sponsorship for pharmaceutical trials from Allergen Research Corporation/Aimmune Therapeutics, Inc. and Astra Zeneca.
Clinical Immunology Coordinator
Division of Rheumatology, Immunology and Allergy
MDL declares that he has no competing interests.
Allergy & Rhinology Department
Royal National Throat, Nose and Ear Hospital
GS is a consultant/advisory board member for ALK, Britannia Pharmaceuticals, CMP Therapeutics, Groupo Uriach, GSK, Merck, Sanofi-Aventis, Schering Plough, and UCB. She has received research funds from ALK, GSK, UCB, and Schering Plough. She has given talks for ALK, GSK, Merck, Schering Plough, and UCB and has co-written articles for Schering Plough and GSK.
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