Last reviewed: June 2018
Last updated: May  2018

European Medicines Agency (EMA) strengthens measures to avoid use of valproate medicines in pregnancy

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

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • presence of risk factors
  • focal neurological deficits
  • focal neurological symptoms (before or after seizure)
  • premonitory sensation or experience (fear, epigastric sensation, déjà vu, jamais vu)
  • temporary hemiparesis
  • temporary aphasia
  • fever, nuchal rigidity, altered mental status

Other diagnostic factors

  • neurocutaneous findings of neurological disease

Risk factors

  • FHx (extended or immediate) of generalised-onset epilepsy
  • previous central nervous system (CNS) infection
  • head trauma
  • prior seizure events or suspected seizure events
  • hx of substance use
  • premature birth
  • multiple or complicated febrile seizures

Diagnostic investigations

1st investigations to order

  • EEG
  • blood glucose
  • FBC
  • electrolyte panel
  • toxicology screen
  • head CT
  • serum prolactin
  • serum CK
Full details

Investigations to consider

  • lumbar puncture
  • MRI brain
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Assistant Professor

Clinical Neurology

University of California, San Francisco

San Francisco

CA

Disclosures

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

Disclosures

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.

Peer reviewers VIEW ALL

Chief

Division of Epilepsy and Sleep

Department of Neurology

Brigham and Women's Hospital

Associate Professor of Neurology

Harvard Medical School

Boston

MA

Disclosures

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

Disclosures

Not disclosed.

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