Safety of intravenous lacosamide in hospitalized children and neonates.
Epilepsia
; 64(9): 2297-2309, 2023 09.
Article
em En
| MEDLINE
| ID: mdl-37287398
ABSTRACT
OBJECTIVE:
Seizures are common in critically ill children and neonates, and these patients would benefit from intravenous (IV) antiseizure medications with few adverse effects. We aimed to assess the safety profile of IV lacosamide (LCM) among children and neonates.METHODS:
This retrospective multicenter cohort study examined the safety of IV LCM use in 686 children and 28 neonates who received care between January 2009 and February 2020.RESULTS:
Adverse events (AEs) were attributed to LCM in only 1.5% (10 of 686) of children, including rash (n = 3, .4%), somnolence (n = 2, .3%), and bradycardia, prolonged QT interval, pancreatitis, vomiting, and nystagmus (n = 1, .1% each). There were no AEs attributed to LCM in the neonates. Across all 714 pediatric patients, treatment-emergent AEs occurring in >1% of patients included rash, bradycardia, somnolence, tachycardia, vomiting, feeling agitated, cardiac arrest, tachyarrhythmia, low blood pressure, hypertension, decreased appetite, diarrhea, delirium, and gait disturbance. There were no reports of PR interval prolongation or severe cutaneous adverse reactions. When comparing children who received a recommended versus a higher than recommended initial dose of IV LCM, there was a twofold increase in the risk of rash in the higher dose cohort (adjusted incidence rate ratio = 2.11, 95% confidence interval = 1.02-4.38).SIGNIFICANCE:
This large observational study provides novel evidence demonstrating the tolerability of IV LCM in children and neonates.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Criança Hospitalizada
/
Anticonvulsivantes
Tipo de estudo:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Observational_studies
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Risk_factors_studies
Limite:
Child
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Humans
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Newborn
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article