Introduction: Valproic acid is an older-generation antiepileptic drug. It has been implicated in liver-related adverse effects. Methods: This is a retrospective study carried out by collecting non-cutaneous reactions linked to Antiepileptic drugs notified to the pharmacovigilance center of Sfax over 9 years. A pharmacovigilance survey was performed according to the French Begaud imputability method. The plasma determination was carried out by an immune-enzymatic method using an INDIKO device in the pharmacology laboratory of the Faculty of Medicine. Results: We collected 8 cases of hepatic cytolysis with varying severity: 1 case of moderately severe cytolysis (case 1), 1 case of fatal cytolysis (case 8) and 6 cases of benign cytolysis (case 2-7). We stopped the administration of this antiepileptic drug in cases 1, 2 and 8 in the face of high transaminase levels ≥ 5 times the upper limit of normal with a favorable outcome for cases 1 and 2 and fatal for case 8. A dosage was requested in the other cases. For cases 3, 4 and 5, the dosage result was within the therapeutic range with associated digestive intolerance. The approach was to avoid this antiepileptic drug with a good outcome. For cases 6 and 7, the result was close to the upper limit of normal, hence a reduction in the dose of valproic acid was recommended with good progress. Conclusion: The management of valproic acid-related hepatic cytolysis depends on their severity, the results of the plasma valproic acid assay and the results of the etiological assessment.
Bouaziz et al. (Thu,) studied this question.