RESUMEN
Antiepileptic drugs (AED) are widely used in therapy. They are mainly indicated in the treatment of epilepsy and some psychiatric pathologies as well as for their analgesic action. Their cutaneous adverse effects (CAE) are common, often mild but sometimes serious. The aim of this work was to study the epidemiological and clinical features of CAE occurring in adults and elderly patients (aged over 20 years-old) and to identify the most implicated AED. We conducted a descriptive retrospective study over a period of five years from January 2017 to December 2022 about CAE of AED in adults and elderly patients notified to The National Center Chalbi Belkahia of Pharmacovigilance (Tunis,Tunisia). All cases were analyzed according to the updates French methods of imputability. We collected 71 cases of patients aged over 20 years old who presented CAE to AED. The age ranged from 20 to 79 years (mean age=44.8 years). The sex ratio F/M was 0.7. AED were indicated for neurological pathology in 70.5% of cases, for psychiatric pathology in 15.9% of cases and for their analgesic action in 12.9% of cases. Epilepsy was the first indication (51.1% of cases). The most notified CAE in our study were drug reaction with eosinophilia and systemic symptoms (DRESS syndrome; 34% of cases), maculopapular exanthema (MPE; 26% of cases), erythematous rash (8% of cases) and photosensitivity in 5% of cases. Severe cutaneous adverse reactions were accounted for 37% of all CAE. The most implicated AED were carbamazepine (52%), phenobarbital (24%) and lamotrigine (18%). However, further study with a larger number of patients and in collaboration with prescribing physicians are needed to better clarify features of CAE associated with AED intake and specify the risk factors, specific to our Tunisian population.
RESUMEN
INTRODUCTION: Carbamazepine could be used on monotherapy or associated to other antiepileptic drugs (AED). In these cases, drug interactions should be taken into account. AIM: To assess the influence of the coadministration of CBZ with other AED on the trough plasmatic concentration (C0) of CBZ in epileptic adults. METHODS: We performed a retrospective study over a period of 9 years in the Department of Clinical Pharmacology in the Tunisian National Centre "Chalbi Belkahia" of Pharmacovigilance. Our study included samples from adult patients receiving CBZ alone or associated to other AED for epilepsy. Trough plasma CBZ plasma concentrations were measured by an immunological method. Included samples were divided in four groups: i/ group 1 (G1) receiving CBZ as monotherapy, ii/ group 2 (G2) treated by CBZ with an enzyme inducer (phenobarbital or phenytoin), iii/ group 3 (G3) taking CBZ associated to an enzyme inhibitor (valproic acid (VPA)), iv/ group 4 (G4), treated by CBZ associated to enzyme inducer (phenobarbital or phenytoin) and enzyme inhibitor (valproic acid) at the same time. RESULTS: There were no significant differences between different groups in age, weight and sex ratio. However statistical analysis showed a significant decrease in C0/D CBZ ratio between G1 and G2 and between G1 and G4 (p<0.001). However, the difference was not significant between G1 and G3 (p=1.2044). CONCLUSION: It is important to check and to prevent the consequences of the interaction between CBZ and other AED in order to avoid inefficiency and toxicity.
