Journal Club

Ekhart C, et al. Neuropsychiatric reactions with the use of Montelukast. BMJ 2022;376:e067554.

https://doi.org/10.1136/bmj-2021-067554

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. These are uncommon and usually mild but can be worrisome and affect the quality of life for patients and their families. Rarely, serious adverse reactions such as depression and suicide have been reported, mostly with prolonged use. Neuropsychiatric symptoms may be attributed to normal behavioural changes in children or to other conditions. Failure to recognize these adverse drug reactions early can result in serious harm to patients and their families.

Among these are:

  1. Sleep disturbances, depression, and agitation (may affect up to 1 in 100 people taking montelukast);
  2. Disturbances of attention or memory (up to 1 in 1,000 people);
  3. Very rarely, hallucinations and suicidal behaviour (up to 1 in 10,000 people).

In the UK, between 2014 and 2018, MHRA received 219 reports of suspected adverse neuropsychiatric reactions to the Yellow Card Scheme, during that time there were approximately 14 million prescriptions of montelukast.

This article reports about a 13-year-old boy who was started on 5mg montelukast per day 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 kind of behaviour earlier. At the time of prescribing, the 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.

Comments of Ms. Suryaprabha

FDA had issued multiple warnings concerning an increased risk of neuropsychiatric AEs after taking montelukast and other leukotriene antagonists, including aggressive behaviour, anxiety, depression, abnormal dreams, excitement, hallucinations, insomnia, irritability, and potential suicidality. From this article, it is clearly understood that we need to carefully monitor all patients who receive long-term Montelukast therapy not only for children but for all ages.

D.-Suryaprabha

D. Suryaprabha

Senior Executive-Clinical Research

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