The latest development in the long history of sodium valproate was the publication of The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, report ‘First Do No Harm’ today.

Looking back, I see that I have written articles about Sodium Valproate in 2017, 2018 and 2019.  To be writing another article today carries mixed emotions: on the one hand satisfaction that this report recognises the errors that have been made and the enormous impact on women and families; but on the other hand it is upsetting to read that some people are still inappropriately prescribed sodium valproate, despite everything that is known about it and the risk of causing avoidable harm.

The ‘First Do No Harm report addresses three medical interventions: sodium valproate, Primodos (a hormone pregnancy test) and pelvic mesh.  My colleague, Rankeshwar Batta, has written an article about the report.

The report gathered people’s experiences of sodium valproate and made major recommendations for change to reduce the risk of harm in the future and support to those who have already suffered harm.

In respect of sodium valproate, the report states “We believe that it has taken far too long for serious action to be taken to reduce the number of women who take sodium valproate during pregnancy while unaware of the risk. Women were not given the information they needed to make an informed choice, and despite the efforts of the valproate toolkit and the PPP, too many women still do not have this information.”

Two of the recommendations in respect of sodium valproate are:

  • identify all of those affected by exposure to sodium valproate in utero to ensure they access support (a patient recall in 2017 has not reached everyone); and
  • additional support should be provided by way of specialist centres of care and an ex gratia scheme to provide discretionary payments to those who have been affected.

On top of the historic and ongoing problems with sodium valproate, the report also identified inadequacies in regulating and monitoring new anti-epileptic drugs.  Leading experts and patients raised concerns that the long-term outcomes of the newer generation drugs are unknown.  The report recommended a registry for all women on anti-epileptic drugs who become pregnant.

In my work I have spoken with people who were prescribed and still are prescribed sodium valproate.  I have heard about the effects it has had on them, their children and even concerns that it might have harmed their grandchildren.  As a team we have a wealth of experience working with families of children who have suffered harm resulting in disability from birth.  Having seen this from personal experience, I fully support the recommendations in the First Do No Harm report and hope it will improve patient care for other women on anti-epileptic medication in the future.

For More Information

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