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.

Epilepsy & Behavior(2020)

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摘要
•According to previous literature, the EMA/FDA referral procedures have been followed by a notable reduction in female valproate users.•This is the first study comparing the impact of recommendations on the contraceptive use among women with valproic acid off-label vs under indication prescription, in a psychiatric center.•The percentage of women used a contraceptive method increased in the period between November 2014 and February 2018 and in the period between March 2018 and April 2019.•No effect was seen in women with epilepsy, probably because the intervention started before.
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关键词
Valproic acid,Regulatory warnings,Epilepsy,Off-label,Psychiatric disorder
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