Last reviewed: June 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 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 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 acknowledgment 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

  • history of major depressive episode(s)
  • ≥7 days of elated, expansive, or irritable mood and increased goal-directed activity/energy different from patient's usual self (mania)
  • inflated self-esteem or grandiosity
  • decreased need for sleep
  • pressure of speech
  • subjective experience that thoughts are racing
  • distractibility
  • excessive involvement in pleasurable activities that have a high potential for painful consequences
  • impairment in functioning

Other diagnostic factors

  • adolescence and young adulthood
  • flight of ideas

Risk factors

  • family history of bipolar disorder
  • history of depression
  • physical and/or sexual abuse
  • poor sleep
  • neurodevelopmental abnormalities
  • lack of maternal warmth/expressed emotion (duration)
  • life events
  • increased sociability and verbal functioning
  • persistent affective symptoms (transition to bipolar disorder)
  • male gender (when ADHD is comorbid)
  • high intellectual performance
  • family conflict
  • symptoms of inattention

Diagnostic investigations

Treatment algorithm

Contributors

Authors VIEW ALL

Professor of Psychiatry

Ohio State Wexner Medical Center

Nationwide Children's Hospital

Center for Innovation in Pediatric Practice

Columbus

OH

Disclosures

RAK is on the data safety monitoring committee for Forrest and Pfizer, but receives no compensation for taking part; he is also an author of references cited in the this topic.

Dr Robert A. Kowatch would like to gratefully acknowledge Dr Bernadka Dubicka and Dr Gabrielle A. Carlson, previous contributors to this monograph. BD is a member of the UK National Institute of Health Research (NIHR) Health Technology Assessment (HTA) panel, and has previously received HTA funding. She is a clinical advisor to NHS England and an occasional advisor to NICE. BD serves as Vice Chair of the Royal College of Psychiatrists child and adolescent faculty, and as Editor on the journal Child and Adolescent Mental Health. BD is an author of several references cited in this monograph. GAC is an author of a number of references cited in this monograph.

Peer reviewers VIEW ALL

Professor

Division of Child & Adolescent Psychiatry

Department of Psychiatry & Behavioral Sciences

University of Washington

Seattle

WA

Disclosures

JM is an author of a number of references cited in this monograph.

Child and Adolescent Psychiatrist

Emeritus Professor of Psychiatry

The Werry Centre for Child and Adolescent Mental Health

Department of Psychological Medicine

University of Auckland

Auckland

New Zealand

Disclosures

JW is an author of a number of references cited in this monograph.

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