Identification of safety signals for antiepileptic drug-associated thrombocytopenia in minor population utilizing the FAERS database

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Author: DUAN Difan ^1, ² CHEN Yan ^2, ³ LIN Gaoyang ^1, ² QIAN Mengying ^2, ³ SHAN Qing ^2, ³  GUO Jinmin ^2, ³

Affiliation: 1.School of Pharmacy, Jinzhou Medical University, Jinzhou 121001, Liaoning Province, China 2.Jinan Key Laboratory of Individualized Clinical Drug Safety Monitoring and Pharmacovigilance Research, Jinan 250000, China 3.Department of Pharmacy, 960th Hospital Joint Logistics Support Force of the People's Liberation Army, Jinan 250000, China

Keywords: Thrombocytopenia Antiepileptic drugs Minor population Food and Drug Administration Adverse Event Reporting System Adverse drug event Signal mining

DOI: 10.12173/j.issn.2097-4922.202603016

Reference: DUAN Difan,CHEN Yan,LIN Gaoyang,QIAN Mengying,SHAN Qing,GUO Jinmin. Identification of safety signals for antiepileptic drug-associated thrombocytopenia in minor population utilizing the FAERS database[J]. Frontiers in Pharmaceutical Sciences,2026,30(7):1196-1204. DOI:10.12173/j.issn.2097-4922.202603016[Article in Chinese]  Copied

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Abstract

Objective To identify safety signals of thrombocytopenia associated with 27 antiepileptic drugs (AEDs) in the minor population using the US Food and Drug Administration Adverse Event Reporting System (FAERS), to provide references for reducing drug-induced thrombocytopenia.

Methods Adverse event reports from the FAERS database between Q1 2013 and Q1 2026 were collected and screened for thrombocytopenia adverse drug events (ADE) in the target population. Cases were categorized by age group: infants (≤ 1 year), toddlers (>1 to <6 years), children (6 to <12 years), and adolescents (12 to <18 years). Signal mining was performed using the reporting odds ratio (ROR) method, the proportional reporting ratio (PRR) method, and the multi-item gamma Poisson shrinker (MGPS) method.

Results A total of 1,200 ADE reports related to thrombocytopenia associated with 27 antiepileptic drugs were collected, involving 699 males (58.25%) and 489 females (40.75%). The children group had the highest proportion of cases (419, 34.92%); 6 AEDs showed positive signals in the 0-18 age cohort, with lamotrigine exhibiting the strongest signal (ROR=18.87); among the four age groups, the adolescent cohort showed the highest number of positive signals for antiepileptic drugs (5 types), with acetazolamide exhibiting the strongest signal (ROR=11.71); the children group followed (4 types), where ethosuximide (ROR=4.68) showed the strongest signal.

Conclusion Significant age-specific and drug-specific patterns in thrombocytopenia associated with antiepileptic drugs, most pronounced in the 6-18 age group. Clinicians should pay attention to the characteristics of thrombocytopenia induced in the target population, identify and compare drug risks, and continuously monitor to reduce medication risks.

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