Off ⁃ label use analysis of novel antiepileptic drugs in Sichuan area: a multicenter survey in pediatric patients

Abstract

Objective To investigate current status and safety about off⁃label use of levetiracetam, topiramate, oxcarbazepine, lamotrigine among pediatric patients in Sichuan area, so as to provide baseline data for formulating guidelines of off ⁃ label drug use. Methods Medical records of pediatric epileptic patients receiving antiepileptic drugs (AEDs) from July 2010 to November 2011 were collected at the following hospitals: West China Second University Hospital of Sichuan University, Chengdu Women's and Children's Central Hospital and Sichuan Provincial People's Hospital. The numbers of patients receiving AEDs and novel AEDs were calculated. Off⁃label drug use and the category of off⁃label drug use were judged according to the indications listed in drug instructions. The incidence of off⁃label drug use was calculated. The patients receiving novel AEDs were devided into on⁃label and off⁃label use groups; the clinical characteristics of these two groups were summarized and adverse reactions of two groups were compared by using χ2 test. Results During the study period, there were totally 854 patients receiving AEDs including 670 patients receiving novel AEDs. Among 670 patients 406 patients off⁃label use group received off⁃label use of novel AEDs, accounting for 47.54% (406/854) of the total patients receiving AEDs and 60.60% (406/670) of patients receiving novel AEDs. When compared with on⁃label use group, off⁃ label use group had more younger patients, more patients with single ⁃ drug use and more patients with generalized epilepsy or epileptic syndrome. The rates of off⁃label using drug were levetiracetam 78.50% (157/200), topiramate 79.81% (253/317), oxcarbazepine 21.32% (42/197) and lamotrigine 33.33% (21/63). The off⁃label use of levetiracetam and topiramate occured in all three aspects: age, single⁃drug use and seizure type. The adverse reaction rates of off⁃label use were oxcarbazepine 16.67% (7/42), topiramate 14.81% (36/243), levetiracetam 10.60% (16/151), lamotrigine 9.52% (2/21). When compared with the adverse reaction rates of on⁃label use group, the difference was not statistically significant (the values of χ2 were 0.375, 0.448, 0.014, 0.109 respectively and the values of P were 0.540, 0.503, 0.906, 0.742 respectively). Conclusion Among pediatric patients in Sichuan area, the rate of off⁃label use of novel AEDs was very high, especially for topiramate and levetiracetam. The follow ⁃ up data of this survey suggested that off⁃label use of novel AEDs with careful observation for adverse reactions had good safety and tolerance.

DOI：10.3969/j.issn.1672⁃6731.2012.05.008