Adverse events associated with Stiripentol in children aged 0–17 years: An analysis of a real-world pharmacovigilance database

Abstract

Objective

To analyze the occurrence of adverse drug events (ADEs) associated with Stiripentol (STP) use in children aged 0–17 years in real-world clinical settings. Methods:ADE reports on STP in children aged 0–17 years were collected from the WHO Global Case Safety Pathology Reporting Database (VigiBase), the U.S. Food and Drug Administration’s Spontaneous Adverse Event Reporting System database (FAERS), and the European Medicines Agency’s Pharmacovigilance database (Eudra Vigilance). Pharmacovigilance signals were identified through Reporting Odds Ratio (ROR), and Proportional Reporting Ratio (PRR).

Results

In total, 31,990 ADEs were reported with “Stiripentol” as the primary suspect drug. This includes 595 ADEs from the Eudra Vigilance, 1,353 ADEs from the FAERS, and 998 ADEs from the VigiBase. All three databases indicate a higher incidence of ADEs related to STP in the categories of nervous system disorders, general disorders and administration site conditions, injury, poisoning and procedural complications, and metabolism and nutrition disorders. A higher proportion of children aged 3–11 years reported (16.48 %–32.44 %). The FAERS data shows that cerebellar atrophy (PRR of 332.94, ROR of 532.10) is the strongest signal for children aged 0–2 years, while changes in seizure presentation (PRR of 110.76, ROR of 121.06) is the strongest signal for children aged 3–11 years. For children aged 12–17 years, seizures (PRR of 46.99, ROR of 47.40) and decreased appetite(PRR of 45.51, ROR of 45.96) are the strongest signals. The Eudra Vigilance results show that boys have higher ADEs than girls for investigations, blood and lymphatic system disorders, hepatobiliary disorders, infections and infestations in children aged 0–17 years. On the other hand, girls have higher ADEs than boys for skin and subcutaneous tissue disorders, injury, poisoning and procedural complications, general disorders and administration site conditions, and gastrointestinal disorders.

Conclusion

In the clinical application of STP in pediatrics, it is important to examine ADEs in Nervous system disorders, Injury, poisoning and procedural complications, General disorders and administration site conditions, and Metabolism and nutrition disorders. Further studies should confirm whether there are age and gender differences in different ADEs.