Last reviewed: June 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 for migraine prophylaxis during pregnancy due to the high risk of congenital malformations and developmental problems in the child. In addition, valproate medicines must not be used in female patients of childbearing age, unless there is a pregnancy prevention programme in place that includes:

  • 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.

See Management: approach See Management: treatment algorithm

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • age >2 years
  • gradual onset of headache
  • normal physical examination

Other diagnostic factors

  • aura
  • nausea and/or vomiting
  • visual disturbance
  • phonophobia
  • occipital headache, ataxia, diplopia, blurred vision, vertigo, and tinnitus
  • unilateral motor or sensory signs and headache
  • ptosis
  • generalized seizure

Risk factors

  • positive family history of migraine
  • chocolate, cheese, and citrus fruits
  • stress
  • hormonal changes
  • alcohol and caffeine
  • volume depletion
  • overuse of analgesics
  • sleep disturbance
  • bright or flickering lights
  • periodic syndromes

Diagnostic investigations

Treatment algorithm

Contributors

Authors VIEW ALL

Consultant Paediatrician

Northampton General Hospital

Northampton

UK

Disclosures

NB declares that he has no competing interests.

Peer reviewers VIEW ALL

Medical Director

Mayo Clinic Pediatric Center

Rochester

MN

Disclosures

KM declares that he has no competing interests.

Consultant Paediatric Neurologist

John Radcliffe Hospital

Oxford

UK

Disclosures

TM declares that he has no competing interests.

Consultant Paediatric Neurologist

John Radcliffe Hospital

Oxford

UK

Disclosures

SJ declares that he has no competing interests.

Associate Professor

Co-Director Pediatric Headache Clinic

University of Maryland School of Medicine

Baltimore

MD

Disclosures

HSJ declares that he has no competing interests.

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