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[Adverse drug reactions of montelukast: from theory to practice. Case report]

Pilar Caudevilla Lafuente1, Juan P García Íñiguez2, Carlos Martín de Vicente3

  • 1Servicio de Pediatría del Hospital Universitario Miguel Servet, Zaragoza, España.

Archivos Argentinos De Pediatria
|July 26, 2021
PubMed

Insights

Montelukast, used for asthma, can cause adverse drug reactions (ADRs) in children, including sleep disturbances and behavioral changes. These reactions, though rare, may necessitate stopping the medication.

Area of Science:

  • Pediatric Pulmonology
  • Pharmacovigilance
  • Clinical Pediatrics

Background:

  • Montelukast is a common treatment for pediatric recurrent wheezing and asthma.
  • Adverse drug reactions (ADRs), particularly neuropsychiatric ones, are known side effects in children.
  • Understanding the real-world incidence and presentation of montelukast-associated ADRs is crucial.

Observation:

  • A retrospective study analyzed 348 pediatric patients treated with montelukast over five years.
  • 20 patients (5.7%) experienced adverse drug reactions (ADRs) requiring discontinuation.
  • Common symptoms included insomnia, hyperactivity, nightmares, abdominal pain, and extremity paresthesia.

Findings:

  • Sleep disorders (insomnia, nightmares) were the most frequent ADRs observed.
  • New symptoms like limb paresthesia were noted in two patients, not previously reported in pediatric populations.
  • ADRs emerged within days to months of treatment initiation and resolved upon cessation.

Implications:

  • Clinicians should be vigilant for neuropsychiatric and other ADRs in children treated with montelukast.
  • The findings highlight the importance of monitoring for both known and potentially novel side effects.
  • Prompt recognition and management of ADRs can improve patient outcomes and adherence.

Keywords:
Montelukastchilddrug-related side effects and adverse reactionsleukotriene antagonistssleep initiation and maintenance disorders

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