A class action for the side effects of sodium valproate has been started in France on behalf of children who sustained foetal valproate syndrome in the womb.
Sodium valproate is an active ingredient of the drug Epilim. Epilim was introduced in Ireland in 1983 after successfully treating patients in France for epilepsy and bipolar disorder for almost twenty years. Because it works by stabilising electrical activity in the brain, Epilim has also been prescribed for migraine and chronic pain.
Unbeknown to the medical profession in Ireland, pregnant women taking Epilim break down the sodium valproate and it is absorbed into the bloodstream as valproic acid. The valproic acid travels along the bloodstream and into the womb, where it can have an adverse effect on the development of the foetus. Children who have sustained foetal valproate syndrome in the womb have been born with a wide range of health issues from autism to spina bifida, and from a cleft palate to kidney development problems.
The side effects of sodium valproate during pregnancy were identified before the drug was introduced in Ireland, but the evidence was allegedly covered up due to not being sufficiently conclusive. Small scale studies have also failed to conclusively prove a link between Epilim and the side effects of sodium valproate during pregnancy, but now France’s National Agency for the Safety of Medicines (ANSM) has looked deeper into the issue and produced an alarming report.
ANSM researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken the French-branded equivalent of Epilim during their pregnancies. The agency believes it has identified up to 4,100 children suffering from the side effects of sodium valproate and discovered that hundreds of stillbirths during the period were also attributable to foetal valproate syndrome.
The results of ANSM´s research have prompted a class action against in France against the manufacturer of Epilim – Sanofi – on behalf of the children who sustained foetal valproate syndrome in the womb. The parents of the children claim that Sanofi did not do enough to warn the medical profession of the risks associated with taking Epilim during pregnancy and the side effects of sodium valproate.
In Ireland, it is not known how many children have been diagnosed with foetal valproate syndrome. A support group – the FACS Forum – has called on the government to conduct an audit to identify the scale of the problem in Ireland and what support measures are needed for families. For further information, the FACS Forum can be reached via the disability-federation.ie website, or you can speak with a solicitor.