A campaign initiated 17 years ago by two mothers has brought to light the sodium valproate scandal, revealing that the drug's risks to foetuses were known but not disclosed to women of childbearing age.
Janet Williams began investigating after her two sons were diagnosed with developmental delays, which a specialist in 2009 suggested might be linked to her epilepsy medication, Epilim (sodium valproate). She then connected with Emma Murphy, whose five children also experienced difficulties after exposure to the drug.
Their efforts, which included researching at Manchester Central library and secretly recording meetings, eventually uncovered a 2015 document from the Committee on Safety of Medicines (CSM). This document indicated that the CSM had decided against warning women about the drug's harm to foetuses, stating it would cause "fruitless anxiety."
Professor Jill Clayton-Smith, a clinical geneticist, had also identified a cluster of features in children born to women treated for epilepsy in the mid-1990s. Her subsequent formal study, which included Williams's children, helped determine that sodium valproate carries a 10% risk of physical malformations and a 30-40% risk of serious neurodevelopmental disorders in exposed individuals. An estimated 39,399 babies have been affected since the risk was first identified.
Despite a class action suit against manufacturer Sanofi Aventis being discontinued in 2011 due to withdrawn legal aid, the mothers continued their campaign. A government review two years ago promised state compensation, but no payments have yet been made to the estimated 20,000 families affected.