Strengthened Regulatory Position on Sodium Valproate

Department of Health and Social Care written statement – made on 24th April 2018.

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Photo of Lord O'Shaughnessy Lord O'Shaughnessy The Parliamentary Under-Secretary for Health and Social Care

The EU review into the safety of sodium valproate has now been completed and has recommended that a contraindication for valproate should be introduced in pregnancy and in girls and women of child bearing potential unless they enrolled in a Pregnancy Prevention Programme.

Valproate is a very effective treatment for epilepsy and bipolar disorder. For some women with epilepsy it may be the only effective treatment. Use of valproate (Epilim, Depakote and other generic brands) in pregnancy is associated with a 40% risk of persistent neurodevelopmental disorders and a 10% risk of physical birth defects. Clear information on the risks of valproate in pregnancy is failing to reach patients, and the warnings issued over the last 4 years have not had a significant enough impact on valproate prescribing in women of childbearing age. Despite repeated communications on this risk, it is estimated that 400 women in the UK took valproate during pregnancy in 2016.

Following the completion of the EU review, the UK healthcare system will now be making changes to ensure that girls and women of childbearing potential are only taking valproate if there is no other suitable treatment, and that the woman is enrolled in a Pregnancy Prevention Programme. This Programme will ensure that every girl or woman knows about the risks of valproate in pregnancy, that where appropriate she is on effective contraception, and that she has a review by her specialist prescriber at a minimum once a year, when a risk acknowledgement form will be discussed and signed by both prescriber and woman herself.

There are approximately 27,000 women of childbearing age receiving prescriptions for valproate in primary care. Within the coming months, GPs should identify all relevant women and girls on valproate in their practice, check that they are on effective contraception as appropriate, and refer them for specialist review unless they have already had a review in the last year.

Specialist prescribers should assess whether treatment with valproate is necessary for women of childbearing potential referred to them, namely that there is no suitable alternative treatment. If continued treatment is necessary, the woman must be enrolled in the Pregnancy Prevention Programme, be on effective contraception, and understand the need to avoid pregnancy.

Pharmacists will ensure the medicine is dispensed in packs which will include the new pictogram and the warning statement. Pharmacy professionals will also make sure that the GP has discussed the risks in pregnancy with female patients and where this has not happened advise them to make an appointment with their GP to have this discussion at the earliest opportunity.

The Medicines and Healthcare products Regulatory Agency has been working in partnership with professional bodies and the healthcare system to bring together a package of measures to support healthcare professionals in implementing these important changes. Educational materials for healthcare professionals and patients are being sent to GPs and specialist prescribers. NICE has updated its guidelines which mention valproate to reflect the new regulatory measures. GP electronic system providers have provided a search and audit function to facilitate the identification of women of childbearing age on valproate and are updating the alerts for valproate.

The MHRA will be closely monitoring the effectiveness of the new measures for avoiding prescribing of valproate to women of childbearing age and in preventing pregnancies from being exposed to valproate. Relevant data will be published and there will be ongoing follow up to ensure progress is being made.

I would particularly like to thank the families involved the Valproate Stakeholder Network who have shared their experiences and expertise. Their dedication, support and altruism will help to keep future generations of children safe.

This statement has also been made in the House of Commons: HCWS640