Analysis of Adverse Drug Reactions with Carbamazepine and Oxcarbazepine at a Tertiary Care Hospital

Abstract

Adverse drug reactions (ADRs) of carbamazepine (CBZ) and oxcarbazepine (OXC), including severe cutaneous adverse reactions (SCARs) have been constantly reported. The aim of this study is to examine the frequency and clinical features of the ADR caused by CBZ and OXC using the pharmacovigilance database and spontaneous ADR reporting data of tertiary care hospital. Among 10419 cases of prescribing CBZ and OXC, 204 ADR cases were reported. The incidence of ADR was 1.8% and 2.2% for CBZ and OXC, with no significant difference (p=0.169). The most common clinical feature of ADR was skin and subcutaneous tissue disorders. Female patients had relatively more frequent ADR occurrence compared to the male patients(p<0.001). Although mild skin ADRs were more frequent in OXC, nervous system disorders, general disorders and hepatobiliary disorders occurred more often by CBZ. There were 6 reports of severe skin reaction by CBZ, while OXC had none. For CBZ, immediate-release (IR) formulation was reported to cause ADR at 200 mg/day and 400 mg/day, while controlled-release (CR) formulation mostly caused ADR at a dose of 400 mg/day. OXC was reported to cause ADR at both 300 mg/day and 600 mg/day. Based on this limited study, we suggest the possibility of considering OXC a firstline prescription of anti-epileptic drugs due to lower incidence of severe ADRs compared to CBZ. Furthermore given the helpfulness of the ADR reporting system for both clinicians and patients, we should make an effort to reduce under-reporting of ADR.