Posted: April 13th, 2017
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 widely used anti-epilepsy drug sold under the trade name Epilim in Ireland, manufactured by French firm Sanofi. Introduced in Ireland in 1987, the drug was initially used in France for epilepsy and bipolar disorder for almost twenty years. The active ingredient stabilises electrical activity in the brain. More recently, the drug has also been successfully prescribed for migraine and chronic pain.
In the 1980s, it was first identified pregnant women taking Epilim break down the sodium valproate, causing it to be absorbed into the bloodstream as valproic acid. The valproic acid can then be transferred to the unborn child in the womb, where it can have an adverse effect on foetal development. A wide range of health issues have been identified in children exposed to valproic acid, including autism and spina bifida, and from a cleft palate to kidney development problems.
In spite side effects of sodium valproate during pregnancy were identified before the drug was introduced in Ireland, it was still cleared for use by pregnant women by health authorities. It is claimed that evidence linking the drug to birth defects was allegedly covered up due by the company as it was not deemed sufficiently “conclusive”. Small scale studies conducted in France had failed to prove a indisputable link between Epilim and the side effects of sodium valproate during pregnancy. However, since 2006, when Sanofi publicly announced the link between congenital birth defects and their drug, France’s National Agency for the Safety of Medicines (ANSM) has looked deeper into the issue.
ANSM researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken Epilim (sold as Depakine in France) during their pregnancies. The agency believes it has identified up to 4,100 children suffering from the side effects of sodium valproate. Tragically, it 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 by parents of children affected by the drug against in France against the manufacturer Sanofi. 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, and had made large-scale attempts to cover up the evidence of any link.
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.