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Safety of lamotrigine in paediatrics: a systematic review
Oluwaseun Egunsola1, Imti Choonara1, Helen M Sammons1
1Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK.
Insights
Lamotrigine is associated with rash as the most common adverse drug reaction (ADR) in children, often leading to treatment discontinuation. Monotherapy with lamotrigine results in fewer adverse events compared to polytherapy.
Area of Science:
- Pediatric Neurology
- Pharmacovigilance
- Clinical Pharmacology
Background:
- Lamotrigine is a widely used antiepileptic drug in pediatric populations.
- Understanding its safety profile and adverse drug reactions (ADRs) is crucial for effective treatment.
- Comparative safety data with other antiepileptic drugs in children is essential.
Purpose of the Study:
- To identify and characterize adverse drug reactions (ADRs) associated with lamotrigine in pediatric patients.
- To compare the safety profile of lamotrigine with other antiepileptic drugs in children.
- To assess the incidence and reasons for treatment discontinuation due to ADRs.
Main Methods:
- Systematic review of randomized controlled trials (RCTs) identified through comprehensive database searches (EMBASE, MEDLINE, PubMed, Cochrane Library).
- Inclusion criteria focused on pediatric patients (≤18 years) receiving at least one dose of lamotrigine with safety outcomes.
- Primary outcome was lamotrigine safety; secondary outcome was drug interaction.
Main Results:
- 78 articles involving 3783 pediatric patients were analyzed, reporting 2222 adverse events (AEs).
- Rash was the most frequent AE (7.3%), and Stevens-Johnson syndrome occurred rarely (0.09%).
- Treatment discontinuation due to ADRs affected 1.9% of patients, primarily due to rash (58%) and increased seizures (21%).
- Lamotrigine monotherapy was associated with significantly lower incidences of AEs, including headache, somnolence, nausea, vomiting, dizziness, and abdominal pain, compared to polytherapy.
Conclusions:
- Rash is the most common adverse drug reaction to lamotrigine in children and the leading cause for discontinuing treatment.
- Pediatric patients on lamotrigine polytherapy exhibit a higher risk of adverse events compared to those on monotherapy.
- Lamotrigine monotherapy appears to offer a more favorable safety profile in children regarding common adverse events.
Objectives:
To identify adverse drug reactions associated with lamotrigine in children and compare the safety profile with other antiepileptic drugs.
Setting:
Databases EMBASE (1974-April 2015), MEDLINE (1946-April 2015), PubMed and the Cochrane library for randomised controlled trials were searched for studies on safety of lamotrigine.
Participants:
All studies involving paediatric patients aged ≤ 18 years who have received at least a single dose of lamotrigine with safety as an outcome measure were included.
Primary And Secondary Outcome Measures:
The primary outcome measure was safety of lamotrigine. Drug interaction of lamotrigine was the secondary outcome.
Results:
A total of 78 articles involving 3783 paediatric patients were identified. There were 2222 adverse events (AEs) reported. Rash was the most commonly reported AE, occurring in 7.3% of the patients. Stevens-Johnson syndrome was rarely reported, with a risk of 0.09 per 100 patients. Discontinuation due to an adverse drug reaction (ADR) was recorded in 72 children (1.9% of all treated patients). Fifty-eight per cent of treatment discontinuation was attributed to different forms of rash and 21% due to increased seizures. Children on lamotrigine monotherapy had lower incidences of AEs. Headache (p=0.02), somnolence (<0.001), nausea (p=0.01), vomiting (p<0.001), dizziness (p<0.001) and abdominal pain (p=0.01) were significantly lower among children on monotherapy.
Conclusions:
Rash was the most common ADR of lamotrigine and the most common reason for treatment discontinuation. Children receiving polytherapy have a higher risk of AEs than monotherapy users.
Trial Registration Number:
CRD42013006910.
