Adverse drug reactions associated with six commonly used antiepileptic drugs in southern China from 2003 to 2015

Adverse drug reactions associated with six commonly used antiepileptic drugs in southern China from 2003 to 2015

Yanru Du, Jiahe Lin, Jingzan Shen, Siqi Ding, Mengqian Ye, Li Wang, Yi Wang, Xin-Shi Wang, Niange Xia, Rong-Yuan Zheng, Hong Chen, Hui-qin Xu

Abstract Background This active, open observational study aimed to investigate adverse drug reactions (ADRs) associated with six commonly used antiepileptic drugs (AEDs) in southern Chinese outpatients with epilepsy from 2003 to 2015. Methods The Wenzhou Epilepsy Follow-Up Registry Database (WEFURD) was established by a single epilepsy center in China in January 2003 to record AED efficacy and the associated ADRs by registered outpatients diagnosed with epilepsy. We reviewed the data of outpatients who had only taken one or more of six commonly used AEDs, namely, carbamazepine (CBZ), valproate (VPA), lamotrigine (LTG), oxcarbazepine (OXC), topiramate (TPM) and levetiracetam (LEV), and were registered in the WEFURD between 2003 and 2015. We evaluated the ADRs caused by the single or combined use of the above six specific AEDs based on the WHO-UMC scale. The data of the ADRs were categorized by age, sex, number of AEDs related to ADRs, medications, seriousness of ADRs, causality levels of the WHO-UMC scale and system organ class (SOC). The unit of analysis was one ADR. Results A total of 3069 epilepsy outpatients (1807 outpatients with 5049 eligible ADRs and 1262 outpatients without ADRs) were included. The overall ADR rate was 58.88% (1807/3069). An average of 2.79 ADRs (5049/1807) occurred per patient with an ADR; 53.8% of the 5049 ADRs were recorded in females, and 50.4% were caused by monotherapy. Of the ADRs, 10.6% (537/5049) were severe adverse reactions (SARs), including 34 serious adverse effects (SAEs). The SAR rates caused by one, two and three or more AEDs were 9.9, 10.0 and 19.6%, respectively (p 

2019

adverse drug reactions, Antiepileptic drug, Severe adverse reactions, China

DOI: 10.1186/s40360-019-0285-y

BMC Pharmacology and Toxicology

BMC

Therapeutics. Pharmacology, Toxicology. Poisons

EN