Sodium Valproate: The Fetal Valproate Syndrome Tragedy

Summary

In this article, Sodium Valproate: The Fetal Valproate Syndrome Tragedy, Sharon Hartles, member of the Open University’s Harm and Evidence Research Collaborative, reflects upon the use of Sodium Valporate, marketed as Epilim, to treat patients at risk of epilepsy and the subsequent harms in fetal development and birth defects that arose from its use. 

Content

In the UK, Epilim is currently used to treat patients at risk of epilepsy due to its anti-convulsive properties, however it was found that as it is also a teratogen, it can cause an increased risk of developmental, physical and neurological harms to the human embryo or fetus.

For decades, the regulator and manufacturer of Epilim did not disclose to patients how harmful the drug can be and as a result, patients were unable to make appropriate and informed decisions regarding their healthcare.

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Further recommended reading:

• Analysing the Cumberlege Review: Who should join the dots for patient safety? (Patient Safety Learning)
• Findings of the Cumberlege Review: informed consent (Patient Safety Learning)
• First Do No Harm. The report of the Independent Medicines and Medical Devices Safety Review
• Regulatory flaws: Women were catastrophically failed in the mesh, Primodos and Sodium Valproate tragedies (Kath Sansom)