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 in bipolar disorder 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.
See Management: approach See Management: treatment algorithmAssistant Professor of Psychiatry
University of Texas Health Science Center
Houston
TX
SS has received intravenous citalopram for research from Lundbeck UK and participated as a speaker organised by Global Medical Education. SS has third-party indirect share in the form of convertible note in Flow MedTech, Inc (a medical device start-up company).
Dr Sudhakar Selvaraj would like to gratefully acknowledge Dr Prashant Gajwani and Dr David J. Muzina, previous contributors to this topic. PG has served on the speakers' bureau for Merck and Sunovion. DJM is an author of a number of references cited in this topic. DJM has previously received honoraria for research support from Repligen Co. He has also previously received honoraria as a speaker and/or advisor from AstraZeneca, Pfizer, BMS, Wyeth, Sepracor, and GSK. DJM is a full-time employee of Medco.
Head
Mood Disorders Psychopharmacology Unit
University Health Network
Associate Professor of Psychiatry and Pharmacology
University of Toronto
Ontario
Canada
RM has received research funds from Stanley Medical Research Institute and National Alliance for Research on Schizophrenia and Depression (NARSAD). RM is on the advisory boards for AstraZeneca, Bristol-Myers Squibb, France Foundation, GlaxoSmithKline Janssen-Ortho, Solvay/Wyeth, Eli Lilly, Organon, Lundbeck, Biovail, Pfizer, Shire, and Schering-Plough. RM is on the speakers' bureau for Janssen-Ortho, AstraZeneca, Eli Lilly, Lundbeck, Biovail, and Wyeth. RM has received research grants from Eli Lilly, Janssen-Ortho, and Shire.
Professor of Psychological Medicine
University of Newcastle
Honorary Professor
Psychological Treatments Research
Institute of Psychiatry
London
University Department of Psychiatry
Royal Victoria Infirmary
Newcastle upon Tyne
UK
JS has received remuneration for attending advisory boards for AstraZeneca, BSM-Otsuka, Eli Lilly, GSK, and Sanofi-Aventis.
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