Impact of the EMA/FDA alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center

Abstract

Objective: We aimed to evaluate the impact of the European Medicines Agency (EMA) and Food Drug and Administration (FDA) alerts on the use of effective contraceptive method in women of childbearing age undergoing valproic acid treatment in a long-stay psychiatric center.

Material and methods: An interrupted time-series analysis of women of childbearing age admitted in a long-stay psychiatric center (2013-2019), according to the EMA/FDA restrictions dates (October 2014 and February 2018).

Results: Of the 82 cases included, 50 (61.0%) had an 'off-label' prescription. The percentage of cases with a contraceptive method before October 2014 (31.6%) increased to 61.5% after October 2014, p = 0.004. Women with an 'off-label' prescription after 2018 were more likely to use a contraceptive method than those before 2014, and there were not statistically significant differences in women with an 'under indication' prescription.

Conclusions: The recent regulatory restrictions on the use of a contraceptive method had a positive effect, mainly in women with an 'off-label' prescription. No effect was seen in women with epilepsy, probably because the intervention had started long before.

Keywords: Epilepsy; Off-label; Psychiatric disorder; Regulatory warnings; Valproic acid.