Last reviewed: September 2018
Last updated: August  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. In the context of brain abscesses, anticonvulsants (including valproate medicines) are used prophylactically. Under the new restrictions, valproate medicines are contraindicated in epilepsy during pregnancy due to the high risk of congenital malformations and developmental problems in the child. However, the EMA recognizes that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment during pregnancy with appropriate specialist care.

In addition, valproate medicines must not be used in female patients of childbearing potential unless there is a pregnancy prevention program 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

  • male gender
  • age <30 years
  • meningismus
  • headache
  • cranial nerve palsy
  • positive Kernig or Brudzinski sign
  • fever
  • increased head circumference (infants)
  • bulging fontanelles (infants)

Other diagnostic factors

  • neurological deficit
  • papilledema

Risk factors

  • sinusitis
  • otitis media
  • dental procedure/infection
  • meningitis
  • recent neurosurgery
  • congenital heart disease
  • endocarditis
  • diverticular disease
  • hereditary hemorrhagic telangiectasia or AVM
  • diabetes mellitus
  • HIV or immunocompromise
  • intravenous drug use
  • chronic granulomatous disease
  • hemodialysis
  • birth prematurity
  • cystic fibrosis

Diagnostic investigations

1st investigations to order

  • CBC
  • serum erythrocyte sedimentation rate (ESR)
  • serum CRP
  • serum PT and PTT
  • blood culture
  • serum toxoplasma titer
  • MRI with contrast
  • CT head with and without contrast
  • ultrasound head (infants)
Full details

Investigations to consider

  • magnetic resonance spectroscopy (MRS)
  • lumbar puncture (LP) with cerebrospinal fluid (CSF) analysis
  • CT chest, abdomen, and pelvis
  • bone scan
  • mammogram
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Professor

Department of Neurosurgery

SUNY Upstate Medical University

Syracuse

NY

Disclosures

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

Dr Walter A. Hall would like to gratefully acknowledge Dr Peter D. Kim, a previous contributor to this monograph. PDK declares that he has no competing interests.

Peer reviewers VIEW ALL

Professor and Head

Department of Neurosurgery

University of Minnesota

Minneapolis

MN

Disclosures

SH and WAH were colleagues on a faculty of the University of Minnesota between 1991 and 1997 and again between 2004 and 2006. They have coauthored articles on neurosurgical infection.

Staff Physician

Department of Neurological Sciences

Institute of Neurology C. Mondino

Pavia

Italy

Disclosures

SR declares that she has no competing interests.

Use of this content is subject to our disclaimer