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 recognises 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 programme in place that includes:
an assessment of the patient’s potential for becoming pregnant
pregnancy tests before starting and during treatment as needed
counselling 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 algorithm
Common seizure type characterised by loss of consciousness, widespread motor manifestations of tonic contractions followed by clonic jerking movements, and a suppressed level of arousal following the event.
May either reflect an underlying generalised-onset epilepsy or focal epilepsy that has secondarily generalised.
MRI and EEG are essential tests for properly diagnosing an epilepsy syndrome after a generalised tonic-clonic seizure (GTCS). During a GTCS, the EEG will demonstrate bilateral synchrony in the epileptiform activity.
After a GTCS, treatment depends on the type of epilepsy syndrome identified. Generalised-onset epilepsy is treated differently to focal epilepsy. With proper diagnosis, most seizure disorders respond to treatment.
The primary treatment complications include lack of efficacy and medication side effects or idiosyncratic reactions.
A generalised tonic-clonic seizure (GTCS) is a seizure type as identified by specific clinical and EEG criteria.  Clinically, this seizure type classically involves loss of consciousness and a phasic tonic stiffening of the limbs (either symmetrically or asymmetrically), followed by repetitive clonic jerking. The vast majority of these types of seizure are self-limiting without intervention. The observed manifestations of the seizure are correlated on the EEG with bisynchronous epileptiform activity in both cerebral hemispheres. These seizures can occur either in a primary fashion (with onset in a widespread or bilateral distribution) or in a secondary fashion (with onset in one hemisphere or region).
University of California, San Francisco
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.
University of California, San Francisco
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 monograph. DHL declares that he has no competing interests.
Division of Epilepsy and Sleep
Department of Neurology
Brigham and Women's Hospital
Associate Professor of Neurology
Harvard Medical School
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
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