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Published on: November 4, 2010
Pediatric montelukast ingestions reported to Texas poison control centers, 2000-2005
1Epidemiology and Disease Surveillance Unit, Texas Department of State Health Services, Austin, Texas 78756, USA. mathias.forrester@dshs.state.tx.us
Insights
Pediatric ingestions of montelukast (asthma medication) rarely cause serious harm. Most cases in children aged 0-5 years had no or minor effects, with many managed at home.
Area of Science:
- Pediatric Toxicology
- Pharmacovigilance
- Asthma Management
Background:
- Limited data exists on montelukast (asthma drug) toxicity in young children.
- Pediatric ingestions require thorough safety evaluation.
Purpose of the Study:
- To assess the toxicity and outcomes of pediatric montelukast ingestions.
- To evaluate the relationship between ingested dose and adverse effects or management needs.
Main Methods:
- Retrieved data on montelukast ingestions in children aged 0-5 years reported to Texas poison control centers (2000-2005).
- Analyzed a subset of cases with known medical outcomes and doses (mg or mg/kg).
- Evaluated patterns of exposure, outcome, and management site.
Main Results:
- 95% of pediatric montelukast ingestions resulted in no observed effect; 5% had minor effects.
- Higher ingested doses (>100 mg or >5 mg/kg) were associated with increased, but still low, proportions of minor effects.
- Most cases (80%) were managed on-site, with healthcare facility involvement increasing for higher doses.
Conclusions:
- Pediatric ingestions of montelukast, even at high doses (up to 536 mg or 33.71 mg/kg), are unlikely to cause severe adverse effects.
- Most pediatric montelukast ingestions can be safely managed at home, indicating a favorable safety profile in overdose scenarios.
Abstract:
Limited information exists on the toxicity of pediatric ingestions of the drug montelukast used in the treatment of chronic asthma. All ingestions of montelukast involving children age 0-5 yr reported to Texas poison control centers during 2000-2005 were retrieved. For a subset of cases where the final medical outcome and dose in milligrams or milligrams per kilogram were known, the pattern of exposures by final medical outcome and management site was evaluated. There was a total of 3698 cases. Of those cases with a known final medical outcome and dose, the mean dose in milligrams was 42.5 mg (range 0.4-536 mg) and the mean dose in milligrams per kilogram was 3.36 mg/kg (range 0.18-33.71 mg/kg). The final medical outcome was no observed effect in 95% of the cases and minor effect in the remainder of the cases. The patient was managed on site in 80% of the cases. The proportion of cases with a minor effect increased from 5% for ingested dose of < or = 100 mg to 10% for > 100 mg but was 5% for dose < or = 5 mg/kg and > 5 mg/kg. The proportion of cases managed with health care facility involvement increased from 15% for ingested dose of < or = 100 mg to 56% for > 100 mg and rose from 10% for dose < or = 5 mg/kg to 47% for dose > 5 mg/kg. Pediatric montelukast ingestions of doses up to 536 mg or 33.71 mg/kg do not appear likely to result in serious adverse effects and usually can be managed at home.
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