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EMA publishes recommendations on sodium valproate

New measures to avoid the exposure of unborn babies to the epilepsy drug sodium valproate have been announced by the safety committee of the European Medicines Agency (EMA).

The measures, which at the moment are still recommendations, follow an extensive review of valproate, based on feedback from women with epilepsy, carers, healthcare professionals and other experts through a public hearing, stakeholder meeting and scientific advisory group.

What the recommendations say

The Pharmacovigilance Risk Assessment Committee (PRAC) - the safety committee of the EMA - has made the following recommendations for women with epilepsy:

  • In pregnancy - valproate must not be used. However it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.
  • In female patients from the time they become able to have children – valproate must not be used unless the conditions of the new pregnancy prevention programme are met.
  • The PRAC has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy. In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level.
  • A patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.
  • Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.

Pregnancy prevention programme

The main points of the new valproate pregnancy prevention programme are:

  • Assessing patients for the potential of becoming pregnant, and involving the patient in evaluating her individual circumstances and supporting informed decision making,
  • pregnancy tests before starting and during treatment as needed,
  • counselling patients about the risks of valproate treatment,
  • explaining the need for effective contraception throughout treatment,
  • carrying out reviews of treatment by a specialist at least annually,
  • introduction of a new risk acknowledgement form  that patients and prescribers will go through at each such review to confirm that appropriate advice has been given and understood.

What the MHRA says

A spokespersonfor the Medicines Healthcare products Agency said: 'This recommendation is in line with the proposals for a strengthened national regulatory position that the MHRA has been developing with UK stakeholders, including an important contribution from patient and campaign groups, during the past year and championing at EU level as part of the PRAC ‎review. MHRA will issue a full public statement once the review process has completed and a final decision has been confirmed.'

Read the full recommendations.

 

 

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