Abstracts

Rationale: An adverse effect to medication is defined as a noxious effect when drug is used with therapeutic purpose. Among the adverse effects using anti epileptic drugs (AED), severe dermatological effects, hematological disorders, hepatic or pancreatic lesion and neurotoxicity can be seen. The adverse effects, even milder ones, can cause up to 40% of AED failure and poor adherence and control of epilepsy Methods: Descriptive statistical analysis and retrospective study of 15 patients under 18 years old is carried out in this study. Charts of patients hospitalized because of severe adverse effects to AED (SAEAED) in the Hospital de la Misericordia, a pediatric hospital in Bogota, Colombia, were reviewed from 2009 to 2011. The statistical analysis was performed using SPSS 17 Results: In this study, 15 patients with SAEAED were reported, the mean age was 6.5y (2-13y), 60% female, all with partial epilepsies: idiopathic 6%, cryptogenic 40%, symptomatic 53%. Treated on monotherapy 67%, bitherapy 20% and three AED in 13%. The AED used were carbamazepine (CBZ) 53%, valproate (VPA) 46,6%, clobazam (CLB) 20%, oxcarbazepine (OCBZ) 13,3% and vigabatrine (VGB) and lamotrigine (LTG) 6,6% each. 5 patients had associations such as VPA-LTG-CLB, CBZ-VPA, VGB-VPA. Systems involved were dermatological 66,7%; hematological 13,3%(bicytopenia, thrombocitopenia); gastrointestinal 6,7%(hemorrhagic pancreatitis), central nervous system (CNS) (ataxia, impaired consciousness) in 13,3%. 26% of the cases required intensive care because of multiorganic failure, with a mean stay of 9,5 days and also had the longest total inpatient time 13-38 days; two of them because of toxic epidermal necrolysis (TEN), one thrombocytopenia and one pancreatitis. Among the dermatological lesions (10 patients), we found severe rash(3), TEN(2), Stevens Johnson(2), DRESS syndrome(2) and serum-like sickness(1). Most received iminodibenzyl AED (CBZ(5) or OCBZ(1)) p=NS. Also, CBZ was related to CNS symptoms. The treatment to all skin reactions was antihistaminic, and some of them required immunomodulatory agents (corticosteroids(4), immunoglobulin(2), cyclosporine(2)); it was observed also that AED withdrawal improved the hematologic SAEAED, as well as the CNS's ones Conclusions: This study found that most of SAEAED were dermatological, and a tendency to be associated with iminodibenzyl usage as reported elsewhere. We neither find association of SAEAED with age, titration rate, length of treatment nor AED number, confirming its idiosincratic appearance, thus to date they are unpredictable. Also most of them required aggressive management as well as longer stay in hospital in patients sufering dermatological or gastrointestinal effects. Characterizing most frequent and severe effects let physicians to develop a high risk clinical profile which could help in perform earlier diagnosis and better treatment possibilities; however, given its unpredictable nature on clinical basis, can be helpful to develop biomarkers in selected populations to infer further recomendations in order to improve diagnostic yield and outcome