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Severe cutaneous adverse reactions linked to medications in children and adolescents: a pharmacovigilance study based
Yaping Xiao1,2, Hu Guo1,2, Lijuan Deng1,2
1Department of Pharmacy, Chongqing University Three Gorges Hospital, 165 Xincheng Road, Wanzhou District, Chongqing, 404000, China.
Insights
Severe cutaneous adverse reactions (SCARs) in children and adolescents are linked to antiepileptics and anti-infectives, showing high hospitalization and mortality rates. Enhanced pediatric pharmacovigilance is crucial for prevention.
Area of Science:
- Pediatric Pharmacology
- Pharmacovigilance
- Drug Safety
Background:
- Severe cutaneous adverse reactions (SCARs) pose significant risks to children and adolescents due to their unique physiological and immunological characteristics.
- Limited large-scale data exists on drug-specific SCAR patterns in pediatric populations, hindering targeted safety interventions.
Purpose of the Study:
- To analyze the epidemiology, clinical presentations, and drug associations of SCARs in pediatric patients.
- To identify safety signals for SCARs in children and adolescents using the FDA Adverse Event Reporting System (FAERS).
Main Methods:
- Retrieved pediatric SCAR reports (≤18 years) from FAERS (Q1 2004–Q2 2024) using Standardised MedDRA Queries (SMQs).
- Employed multiple disproportionality analyses (ROR, PRR, BCPNN, MGPS, EBGM) to detect safety signals.
- Compared identified signals with existing FDA pediatric drug labeling.
Main Results:
- 7183 pediatric SCAR reports were analyzed, with increasing trends over time, predominantly in adolescents and school-aged children.
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) were most common.
- High hospitalization (64.5%) and mortality (6.3%) rates were observed; 82.7% of cases occurred within 30 days of drug exposure.
- Positive safety signals identified for 38 drugs, including lamotrigine and phenytoin; four drugs lacked corresponding warnings in pediatric labeling.
Conclusions:
- Pediatric SCARs exhibit distinct patterns, characterized by severe outcomes and associations with antiepileptic and anti-infective drugs.
- Strengthening pediatric pharmacovigilance systems and implementing risk-management strategies are essential for preventing SCARs.
- Genotype-guided prescribing may offer a future approach to mitigate SCAR risks in pediatric populations.
Introduction:
Severe cutaneous adverse reactions (SCARs) are rare but potentially life-threatening. Children and adolescents are especially vulnerable due to developmental pharmacology, immature immune systems, and limited premarketing safety data. However, large-scale evidence of drug-specific SCAR patterns in pediatric populations remains limited.
Aim:
To investigate the epidemiology, clinical features, drug associations, and safety signals of SCARs in children and adolescents using the FDA Adverse Event Reporting System (FAERS).
Method:
Reports of SCARs in patients aged ≤ 18 years were retrieved from FAERS from Q1 2004 to Q2 2024 and identified using narrow-scope Standardised MedDRA Queries (SMQs). Data cleaning followed the FDA-recommended procedures. Disproportionality analysis was performed using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN; yielding Information Component, IC), Multi-item Gamma Poisson Shrinker (MGPS), and empirical Bayes geometric mean (EBGM). Drug-label reviews were used to compare the signal detection results with existing safety warnings.
Results:
A total of 7183 pediatric SCAR reports were included. The number of reports has increased over time, with adolescents (13-17 years) and school-aged children (7-12 years) accounting for 68% of cases. The most frequently reported Preferred Terms were drug reaction with eosinophilia and systemic symptoms (DRESS; 32.5%), Stevens-Johnson syndrome (SJS; 27.9%), and toxic epidermal necrolysis (TEN; 19.0%). Hospitalization occurred in 64.5% of cases, and 6.3% were fatal. Among the 2005 cases with available onset time, 82.7% developed within 30 days of drug exposure. Thirty-eight drugs showed positive signals, including lamotrigine, phenytoin, sulfamethoxazole, and phenobarbital. Four drugs, ranitidine, anakinra, clonazepam, and rifampin, showed signals without corresponding warnings in the FDA pediatric labeling.
Conclusion:
SCARs in children and adolescents show distinct patterns, high hospitalization and mortality, and strong links with antiepileptics and anti-infectives. Strengthening pediatric pharmacovigilance, implementing risk-alert systems, and promoting genotype-guided prescribing may help prevent these severe reactions.
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