Impact of the French Agency for the Safety of Medicines and Health Products communication on sodium valproate prescription in women of childbearing potential age

Abstract

Introduction Sodium valproate (VPA) is one of the most prescribed teratogenic drugs in treating epilepsy [1] , [2] or bipolar disorder [3] , [4] . French Agency for the Safety of Medicines and Health Products (ANSM) started in December 2014 a huge information campaign about the risk of using VPA in women of childbearing potential age [5] . The aim of the study is to measure the impact of this information campaign on VPA utilization frequency among women of childbearing potential age. Material and methods The study included all patients aged 15 to 49 years old, having had at least one delivery of VPA or another alternative drug to VPA recorded in the French national health insurance database (SNIIRAM) from January 2014 to December 2016. The rate of VPA exposure has been modeled (Poisson regression) according to gender and time period (before and after intervention of ANSM), taking into account the pathological context (epilepsy or bipolar disorder). Results From SNIIRAM, 2, 187,936 patients were included. Among women of childbearing potential age (N = 1, 142, 659) VPA exposure rate decreases immediately after intervention compared to the period before intervention and compared to men [rate ratio (RR) = 0.969; P Discussion/Conclusion Even if others risk minimization measures as well as important media coverage comply the 2014 ‘Dear Doctor Letter’, the observed impact is still minor, especially among women treated for a psychiatric disorder. The contra indication in France for VPA use in bipolar disorder in women of childbearing potential age without a reliable contraceptive method should modify this result. Pursuing the analysis would be valuable.