Last reviewed: September 2018
Last updated: July  2018

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

In March 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 during pregnancy due to the high risk of congenital malformations and developmental problems in the child. Valproate medicines must not be used in female patients of childbearing potential unless there is a pregnancy prevention programme in place and certain conditions are met. These include:

  • 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. In the context of Huntington’s disease, anticonvulsants (including valproate medicines) are used for the treatment of behavioural and mood problems (e.g., irritability, mood swings, aggression, frequent temper outbursts).

See Management: approach See Management: treatment algorithm

Original source of update



History and exam

Key diagnostic factors

  • positive FHx of Huntington's disease
  • known expansion of the CAG repeat length at the N-terminal end of the huntingtin gene
  • impaired work or school performance
  • personality change
  • irritability and impulsivity
  • chorea
  • twitching or restlessness
  • loss of coordination
  • deficit in fine motor coordination
  • slowed rapid (saccadic) eye movements
  • motor impersistence
  • impaired tandem walking

Other diagnostic factors

  • concentration impairment/task anxiety or apathy
  • cognitive decline relative to spouse/siblings
  • changes in personal habits/hygiene
  • disinhibition or unusually anxious behaviour
  • depression, obsessions, and compulsions

Risk factors

  • expansion of the CAG repeat length at the N-terminal end of the huntingtin gene
  • other genetic factors
  • family history

Diagnostic investigations

Investigations to consider

  • CAG repeat testing
  • MRI or CT scan
Full details

Treatment algorithm



Authors VIEW ALL

Professor of Clinical Neurology

Honorary Consultant Neurologist

UCL Institute of Neurology




SJT receives grant funding for her research from CHDI Foundation, the BBSRC, Dementia and Neurodegenerative Disease Network UK, European Huntington’s Disease Network, Huntington’s Disease Association of the UK, the Medical Research Council UK, Takeda Pharmaceuticals, the UCL/UCLH Biomedical Research Centre, and the Wellcome Trust. In the past year, SJT has been on advisory boards or had consultancies with F. Hoffmann-La Roche Ltd, Ixico Technologies, Shire Human Genetic Therapies, Takeda Pharmaceuticals International, and TEVA Pharmaceuticals. All honoraria for these consultancies and advisory boards were paid to UCL. Through the offices of UCL Consultants Ltd, a wholly owned subsidiary of University College London, SJT has undertaken consultancy services for F. Hoffmann-La Roche Ltd and GSK. ST is also an author of references cited in this topic.

Wellcome Trust Clinical Research Fellow

UCL Institute of Neurology




PM declares that he has no competing interests.

Senior Lecturer in Neuropsychiatric Genetics

University of Manchester

Manchester Academic Health Sciences Centre and Central Manchester University Hospitals NHS Foundation Trust

St Mary's Hospital




DC has received fees for advisory board membership from Hoffmann-La Roche Ltd.

Dr Sarah Tabrizi, Dr Peter McColgan, and Dr David Craufurd would like to gratefully acknowledge Dr Marianne Novak and Dr Francis Walker, previous contributors to this monograph. FW declares that he has no competing interests. MN is author of a reference cited in this monograph.

Peer reviewers VIEW ALL


Massachusetts Eye and Ear Infirmary

Harvard Medical School




AP declares that he has no competing interests.

Resident Neurology

Neurological Clinical Research Unit

Institute of Molecular Medicine




TM declares that he has no competing interests.

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