In 2018 the EMA announced stronger measures aimed at avoiding the exposure of babies to valproate medicines in the womb. Under the new restrictions, valproate medicines are contraindicated in epilepsy during pregnancy due to the high risk of congenital malformations and developmental problems in the child. However, the EMA recognizes that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment during pregnancy with appropriate specialist care.
In addition, valproate medicines must not be used in female patients of childbearing potential unless there is a pregnancy prevention program in place that includes:
an assessment of the patient’s potential for becoming pregnant
pregnancy tests before starting and during treatment as needed
counseling about the risks of valproate treatment and the need for effective contraception throughout treatment
a review of ongoing treatment by a specialist at least annually
a risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.
The EMA said the new measures were put in place because of evidence suggesting that information on the risks of valproate use in pregnancy was still not getting through to women despite earlier steps aimed at ensuring this.
See Management: approach See Management: treatment algorithmAssistant Professor
Clinical Neurology
University of California, San Francisco
San Francisco
CA
VRR is an author of a number of references cited in this monograph. He served as a paid consultant for NeuroPace, Inc., manufacturer of the Responsive Neurostimulation (RNS) System.
Associate Professor
Clinical Neurology
University of California, San Francisco
San Francisco
CA
JDH has received research funding and consultancy funds from UCB Inc.
Dr Vikram R. Rao and Dr John D. Hixson would like to gratefully acknowledge Dr Daniel H. Lowenstein, a previous contributor to this topic. DHL declares that he has no competing interests.
Chief
Division of Epilepsy and Sleep
Department of Neurology
Brigham and Women's Hospital
Associate Professor of Neurology
Harvard Medical School
Boston
MA
EBB has received speaking fees from ICR Pharma, Novartis, Abbott Laboratories, GlaxoSmithKline, and Pfizer. He has received consulting fees from ICR Pharma, Genzyme, and Spherics, and research funding from UCB Pharma. Unfortunately we have since been made aware that EBB is deceased.
Honorary Clinical Senior Lecturer
University of Glasgow
Institute of Neurological Sciences
Glasgow
UK
Not disclosed.
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