Recommendations in Cumberlege Report on prescription of Sodium Valproate in pregnancy still not implemented and now calls for it to be banned.

It is now three months since The Baroness Cumberlege Report – First do no harm was published. Yet still up to 25 babies per month are being born with disabilities, because their mothers continue to take Sodium Valproate, despite the risks of the drug being known.

The Cumberlege Report highlighted that approximately 27,000 women of childbearing age take Sodium Valproate in the UK for treatment of epilepsy. However, it is well known that Sodium Valproate can cause physical and neurodevelopment problems in babies, when their mother has taken it during pregnancy.

Currently, the guidance for healthcare professionals is that, all girls and women of childbearing potential should only be treated with Sodium Valproate if they have received counselling about the risks; they are on highly effective contraception; and they are reviewed by their specialist at least annually. Yet evidence from the Report suggested that many women are still not being given the information that they require in order to make an informed choice about their treatment. Healthcare professionals continue to fail to explain the risks of taking the drug and alternative treatment options.

The report recommended that NHS England and Improvement write directly to all women and girls of childbearing potential asking them to see their general practitioner or specialist, to talk about their continuing prescription and the risks involved with the letter copied to the GP. It also recommended an online system, which includes confirmation that the risks had been discussed within the previous year. This system could then be accessed by pharmacists at the point of dispensing.

In an open letter to Matt Hancock on 14 October 2020, Jeremy Hunt, Chair of the Health and Social Care Committee, has gone further, and called for an urgent ban on the drug being prescribed to women who are pregnant.

It is hugely concerning that despite the recommendations in the Report, three months has now lapsed and no steps have been taken by the government to “do no harm”.

Given the period over which the risks of Sodium Valproate to babies has been known; the recommendations in the Cumberlege Report; and the time that continues to pass, it is imperative that the government takes action, without further delay, to prevent significant harm to more babies.

Further, those families, whose lives have been affected by Fetal Valproate Spectrum Disorder, must have the recommendations implemented, to help them access the support and services that they desperately need.

If you believe that you or your child have been affected a prescription of Sodium Valproate, CL Medilaw have specialist clinical and medical negligence solicitors that may be able to help you seek redress for the failings in you care.

Please call us on 0345 241 0154 and one of our specialist team will be able to offer advice about what you should do next.

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