Last reviewed: September 2018
Last updated: May  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. The EMA did not comment specifically on use of valproate during pregnancy in schizoaffective disorder, but it is reasonable to extrapolate that this is also contraindicated.

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.

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History and exam

Key diagnostic factors

  • positive symptoms
  • negative symptoms
  • disorder of perception
  • delusions
  • disturbances in emotions
  • disorders of stream and form of thought
  • cognitive abnormalities
  • deficit symptoms

Other diagnostic factors

  • neurological deficit
  • family history
  • disorders of behavior

Risk factors

  • family history of schizophrenia
  • substance use
  • age of the father at patient's birth
  • psychological stress
  • environment

Diagnostic investigations

1st investigations to order

  • urine drug screen
  • sexually transmitted disease screening
  • complete blood count
  • thyroid function tests
Full details

Investigations to consider

  • laboratory studies to exclude organic causes
  • CT/MRI head
  • EEG
Full details

Treatment algorithm


Authors VIEW ALL

Robert G. Bota

Associate Clinical Professor of Psychiatry

University of California




RGB declares that he has no competing interests.

Adrian Preda

Health Sciences Professor

Department of Psychiatry and Human Behavior

University of California, Irvine School of Medicine




AP declares that he has no competing interests.

Peer reviewers VIEW ALL

Professor of Psychiatry

University of Missouri Kansas City

Kansas City



KS declares that he has no competing interests.

Associate Professor of Psychiatry

University of Maryland School of Medicine




WTR declares that he has no competing interests.

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