Last reviewed: June 2018
Last updated: June  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 in bipolar disorder during pregnancy because of 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 algorithm

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • previous suicide attempt
  • current suicide plan
  • access to lethal means
  • hx of psychiatric disease, including substance abuse
  • FHx of suicide or mental illness

Other diagnostic factors

  • chronic medical illness, disability, or disfigurement
  • significant psychosocial factors
  • personality and/or maladaptive traits

Risk factors

  • current suicidal plan
  • previous suicide or self-harm attempt
  • history of mental disorder, including substance abuse
  • availability of lethal means
  • history of childhood sexual or physical abuse
  • family history of death by suicide
  • male sex
  • prison inmate
  • family history of psychiatric illness
  • physical illness (especially of the central nervous system) and/or physical impairment
  • marital status (divorced, single, widowed)
  • professions/occupations (unemployed, self-employed, agricultural workers, medical and dental professionals)
  • psychosocial stressors

Diagnostic investigations

1st investigations to order

  • Tool for Assessment of Suicide Risk (TASR)
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Stan Kutcher

Professor

Department of Psychiatry

Dalhousie University

Sun Life Financial Chair in Adolescent Mental Health

IWK Health Centre and Dalhousie University

Director

WHO Collaborating Center for Mental Health Training and Policy

Dalhousie University

Halifax

Nova Scotia

Canada

Disclosures

SK has received research grants from various foundations and national granting agencies (none from either the pharmaceutical nor psychotherapy industries) to support some of his academic work. He is employed by a university and hospital, and sees patients who sometimes present with a suicide attempt. He has also co-authored a textbook on suicide risk assessment and management, published in 2007 and the second edition in 2012.

Dr Stan Kutcher would like to gratefully acknowledge Dr Magdalena Szumilas, a previous contributor to this monograph. MS is an author of a reference cited in this topic.

Peer reviewers VIEW ALL

Professor of Psychiatry and Mental Health

Departamento de Saude Mental

Faculdade de Ciencias Medicas

Universidade Nova de Lisboa

Lisbon

Portugal

Disclosures

RG declares that he has no competing interests.

Assistant Clinical Professor of Psychiatry

University of California

San Diego

Veterans Hospital

La Jolla

CA

Disclosures

SR declares that he has no competing interests.

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