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13.12.2021 | position paper

FDA warning montelukast 03.2020—Statement of the Austrian working group of pediatric pulmonology and allergology

verfasst von: Anna Zschocke, MB BCh, Prim. Priv. Lect. Dr. Fritz Horak, Univ. Prof. Dr. Ernst Eber, Prim. Univ. Prof. Mag. Dr. Thomas Frischer, Prim. Univ.-Prof. Dr. Burkhardt Simma, Dr. Wolfgang Stetzl, Prim. Univ. Prof. Dr. Josef Riedler, Univ. Prof. Dr Zsolt Szépfalusi, Univ. Prof. Dr. Angela Zacharasiewicz, MBA

Erschienen in: Wiener klinische Wochenschrift | Ausgabe 1-2/2022

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Summary

Montelukast, a leukotriene receptor antagonist (LTRA) has been approved for use in Europe since 1998. Indications for use (from the age of 6 months) include mild to moderate asthma, seasonal allergic rhinitis with asthma, and the prevention of exercise-induced asthma episodes. The psychiatric side effects of montelukast have been known for the last 10 years; in the case of such symptoms benefits and risks should be considered. Due to potential life-threatening psychiatric adverse events, particularly suicide, a black box warning was issued. In this statement the Austrian working group of pediatric pulmonology and allergology advises that treatment with montelukast should be started only after critical evaluation. Treatment should be stopped on the occurrence of any neuropsychiatric side effects.
Literatur
2.
Zurück zum Zitat Food US, Administriation D. 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 Saf Commun. 2020;. https://www.fda.gov/media/135840/download (last accessed 10.10.2021). Food US, Administriation D. 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 Saf Commun. 2020;. https://​www.​fda.​gov/​media/​135840/​download (last accessed 10.10.2021).
6.
Zurück zum Zitat Sansing-Foster V, Haug N, Mosholder A, Cocoros NM, Bradley M, Ma Y, et al. Risk of psychiatric adverse events among montelukast users. J Allergy Clin Immunol Pract. 2021;9(1):385–93.CrossRef Sansing-Foster V, Haug N, Mosholder A, Cocoros NM, Bradley M, Ma Y, et al. Risk of psychiatric adverse events among montelukast users. J Allergy Clin Immunol Pract. 2021;9(1):385–93.CrossRef
8.
Zurück zum Zitat Hussein HR, Gupta A, Broughton S, Ruiz G, Brathwaite N, Bossley CJ. A meta-analysis of montelukast for recurrent wheeze in preschool children. Eur J Pediatr. 2017;176(7):963–9.CrossRef Hussein HR, Gupta A, Broughton S, Ruiz G, Brathwaite N, Bossley CJ. A meta-analysis of montelukast for recurrent wheeze in preschool children. Eur J Pediatr. 2017;176(7):963–9.CrossRef
9.
Zurück zum Zitat Bousquet J, Schünemann HJ, Togias A, et al. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020;145(1):70–80.CrossRef Bousquet J, Schünemann HJ, Togias A, et al. Next-generation Allergic Rhinitis and Its Impact on Asthma (ARIA) guidelines for allergic rhinitis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE) and real-world evidence. J Allergy Clin Immunol. 2020;145(1):70–80.CrossRef
10.
Zurück zum Zitat Klimek L, Bachert C, Pfaar O, et al. ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergol Sel. 2019;3(1):22–50.CrossRef Klimek L, Bachert C, Pfaar O, et al. ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergol Sel. 2019;3(1):22–50.CrossRef
11.
Zurück zum Zitat Seresirikachorn K, Mullol J, Limitlaohaphan K, Asvapoositkul V, Snidvongs K. Leukotriene receptor antagonist addition to intranasal steroid: systematic review and meta-analysis. Rhinology. 2021;59(1):2–9.CrossRef Seresirikachorn K, Mullol J, Limitlaohaphan K, Asvapoositkul V, Snidvongs K. Leukotriene receptor antagonist addition to intranasal steroid: systematic review and meta-analysis. Rhinology. 2021;59(1):2–9.CrossRef
Metadaten
Titel
FDA warning montelukast 03.2020—Statement of the Austrian working group of pediatric pulmonology and allergology
verfasst von
Anna Zschocke, MB BCh
Prim. Priv. Lect. Dr. Fritz Horak
Univ. Prof. Dr. Ernst Eber
Prim. Univ. Prof. Mag. Dr. Thomas Frischer
Prim. Univ.-Prof. Dr. Burkhardt Simma
Dr. Wolfgang Stetzl
Prim. Univ. Prof. Dr. Josef Riedler
Univ. Prof. Dr Zsolt Szépfalusi
Univ. Prof. Dr. Angela Zacharasiewicz, MBA
Publikationsdatum
13.12.2021
Verlag
Springer Vienna
Erschienen in
Wiener klinische Wochenschrift / Ausgabe 1-2/2022
Print ISSN: 0043-5325
Elektronische ISSN: 1613-7671
DOI
https://doi.org/10.1007/s00508-021-01981-1