Analysis of Adverse Drug Reactions in Pediatric Patients with Epilepsy: An Intensive Pharmacovigilance Study

    November 2023 in “ Children ”
    Eva García, Lizbeth Naranjo, Luz Adriana Pichardo‐Macías, María Josefa Bernad Bernad, Lucila I. Castro‐Pastrana, Matilde Ruiz García, Teresa Bernal, José M. Solı́s, David Calderón Guzmán, Luisa Díaz–García, Julieta Griselda Mendoza‐Torreblanca, Juan Luis Chávez‐Pacheco
    TLDR Many pediatric epilepsy patients experience preventable severe adverse drug reactions, especially with certain medications and risk factors.
    The study analyzed adverse drug reactions (ADRs) in 315 pediatric epilepsy patients over 112 months, identifying 548 ADRs in 211 patients. The most frequent ADRs were drowsiness, irritability, thrombocytopenia, and alopecia, primarily associated with valproic acid (VPA), levetiracetam (LEV), and phenytoin (PHT). Polytherapy and younger age were significant risk factors for ADRs, with malnutrition also contributing to severe ADRs. LEV and oxcarbazepine (OXC) caused more non-severe ADRs, while PHT caused more severe ADRs. Notably, most severe ADRs were preventable, highlighting the importance of intensive pharmacovigilance in improving medication safety in pediatric patients.
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