16-03-2018| New valproate guidelines

16 March 2018
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Background

Valproate is a medicine licensed in Ireland to treat epilepsy and bipolar disorder. It is known as EpilimĀ® in Ireland and other brand names exist in other countries.

If a woman becomes pregnant while taking valproate (EpilimĀ®), their baby is at risk of serious birth defects and developmental disorders. The EMA, the European medicines regulator, has recently recommended new restrictions so that women on this medicine are made aware by their healthcare team of the risks to their baby of taking this medicine while pregnant.

Recommendations

The new European Medicines Agency recommendations on valproate in February 2018 include:

  • For women with epilepsy, EMA state that valproate must not be used in pregnancy. However, it is recognised that for some women, 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 a new Pregnancy Prevention Programme are met.

What are the main points of the new valproate pregnancy prevention programme?

  • 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.

Important Valproate information booklets

The Valproate toolkit below contains a patient information leafet, and resources for health professionals. It was produced by the National Clinical Programmes for Epilepsy, Mental Health and Medicines Management in consultation with the HPRA and patient groups and aims to reinforce the safety message for healthcare professionals and patients.

See below for the online toolkit. 

Valproate Patient Information Booklet.pdf

Valproate Guidelines.pdf

Valproate Checklist.pdf 

 

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