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Neuropsychiatric reactions with the use of montelukast

BMJ 2022; 376 doi: https://doi.org/10.1136/bmj-2021-067554 (Published 29 March 2022) Cite this as: BMJ 2022;376:e067554
  1. Corine Ekhart, pharmacist1,
  2. Florence van Hunsel, pharmacist, epidemiologist1,
  3. Vanessa Sellick, administrator of the Montelukast Side Effects Support and Discussion Group2,
  4. Tjalling de Vries, paediatrician3
  1. 1Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands
  2. 2Montelukast (Singulair) Side Effects Support and Discussion Group, International Group, Melbourne, Victoria, Australia
  3. 3Department of Paediatrics, Medical Centre Leeuwarden (MCL), Leeuwarden, The Netherlands
  1. Corresponding author: C Ekhart c.ekhart{at}lareb.nl

What you need to know

  • Montelukast, used in the treatment of asthma and allergic rhinitis, can cause serious mental health adverse effects such as nightmares, aggression, depression, and suicidal ideation

  • These adverse effects have been reported in patients of all ages, with and without pre-existing psychiatric disease, while taking montelukast or rarely after discontinuation

  • Inform patients and carers of these adverse reactions by discussing the patient information leaflet at the time of prescribing montelukast, and review within one month of initiation and regularly thereafter

A 13 year old boy was started on 5 mg montelukast daily in addition to low dose inhaled corticosteroids to treat his asthma. Within a few days, his mother noted that he was constantly arguing and wanted to hit and kick other people. He had not shown this behaviour earlier. At the time of prescribing, their doctor had asked for any history of psychiatric illnesses in their family, which they had none. The doctor had advised her to observe the child and report any changes in behaviour after starting the drug.

Montelukast, used in patients with asthma or allergic rhinitis, is associated with a risk of neuropsychiatric adverse reactions (see box 1). These are uncommon and usually mild but can be worrisome and affect quality of life for patients and their families. Rarely, serious adverse reactions such as depression and suicide have been reported, mostly with prolonged use.8 Neuropsychiatric symptoms may be attributed to normal behavioural changes in children or to other conditions. Failure to recognise these adverse drug reactions early can result in serious harm to patients and their families.

Box 1

Regulatory approval and safety warnings

  • 1998—Marketing approval of montelukast

  • 2008—US Food and Drug Administration (FDA) posts early communication about investigating a possible association between use of montelukast and behaviour or mood changes, suicidality, and suicide1

  • 2009—Adaptation of US product information and …

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