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

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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.

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Authors and Affiliations

  1. Department of Pediatric and Adolescent Medicine Innsbruck, Pediatrics III, Anichstr. 35, 6020, Innsbruck, Austria

    Anna Zschocke MB BCh

  2. Allergy Center Vienna West, Hütteldorfertr. 46, 1150, Vienna, Austria

    Fritz Horak

  3. Clinical Department of Pediatric Pulmonology and Allergology University Clinic for Pediatric and Adolescent Medicine, Graz University, Auenbruggerplatz 34/2, 8036, Graz, Austria

    Ernst Eber

  4. Department of Pediatric and Adolescent Medicine, Klinik am Ottakring, Montleartstr. 37, 1160, Vienna, Austria

    Thomas Frischer &  Angela Zacharasiewicz MBA

  5. Department of Pediatric and Adolescent Medicine, State Hospital of Feldkirch, Carinagasse 47, 6800, Feldkirch, Austria

    Burkhardt Simma &  Wolfgang Stetzl

  6. Department of Pediatric and Adolescent Medicine, Kardinal Schwarzenberg Hospital, Kardinal-Schwarzenbergstr. 2–6, 5620, Schwarzach, Austria

    Josef Riedler

  7. Clin. Department for Pediatric Pulmonology, Allergology and Endocrinology, University Clinic for Pediatric and Adolescent Medicine, Währinger Gürtel 18–20, 1090, Vienna, Austria

    Zsolt Szépfalusi

Authors
  1. Anna Zschocke MB BCh
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  2. Fritz Horak
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  3. Ernst Eber
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  4. Thomas Frischer
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  5. Burkhardt Simma
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  6. Wolfgang Stetzl
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  7. Josef Riedler
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  8. Zsolt Szépfalusi
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  9. Angela Zacharasiewicz MBA
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Corresponding author

Correspondence to Anna Zschocke MB BCh.

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Conflict of interest

A. Zschocke, F. Horak, E. Eber, T. Frischer, B. Simma, W. Stetzl, J. Riedler, Z. Szépfalusi and A. Zacharasiewicz declare that they have no competing interests.

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Zschocke, A., Horak, F., Eber, E. et al. FDA warning montelukast 03.2020—Statement of the Austrian working group of pediatric pulmonology and allergology. Wien Klin Wochenschr 134, 86–88 (2022). https://doi.org/10.1007/s00508-021-01981-1

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  • DOI: https://doi.org/10.1007/s00508-021-01981-1

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