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 program 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
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. In the context of Huntington disease, anticonvulsants (including valproate medicines) are used for the treatment of behavioral and mood problems (e.g., irritability, mood swings, aggression, frequent temper outbursts).
See Management: approach See Management: treatment algorithmProfessor of Clinical Neurology
Honorary Consultant Neurologist
UCL Institute of Neurology
London
UK
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
London
UK
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
Manchester
UK
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.
Instructor
Massachusetts Eye and Ear Infirmary
Harvard Medical School
Boston
MA
AP declares that he has no competing interests.
Resident Neurology
Neurological Clinical Research Unit
Institute of Molecular Medicine
Lisbon
Portugal
TM declares that he has no competing interests.
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