Class Action Made Against Epilim for Birth Defects

Claims for birth defects due to taking Epilim while pregnant have been made in France on behalf of up to 4,100 children with foetal valproate syndrome.

Epilim is the trade name of a French anti-epilepsy drug manufactured by Sanofi. The active ingredient sodium valproate to control electrical activity in the brain.  It is now commonly prescribed to treat bipolar disorder, migraines, and chronic pain as well as epilepsy. Originally introduced in France in 1967, Epilim was passed for use in Ireland in 1983.

Just as it was introduced into Ireland, claims for birth defects due to taking Epilim while pregnant started to emerge in France. It was thought that the sodium valproate entered the bloodstream as valproic acid. This, when transferred to the foetus, caused foetal congenital and development issues.

However, evidence of birth defects due to taking Epilim was considered inconclusive by French authorities. Pregnant women continued to be prescribed the drug as normal. Despite the inconclusive evidence, there was still a large proportion of children born to mothers who had taken the drug born with defects. Further investigations ensued. It was only in 2006 that the manufacturers of the drug – Sanofi – warned users that sodium valproate may have adverse effects and advised the medical profession to advise pregnant mothers of the potential risks.

Research conducted several years later by France´s social affairs inspectorate – IGAS – found the majority of in spite of the warning, doctors and pharmacists were unaware of the risks associated with Epilim to pregnant women. The research prompted the inspectorate to conduct a small scale study in the Rhone-Alpes region last year, where a much higher than expected rate of birth defects due to taking Epilim while pregnant was conclusively discovered.

This prompted France’s National Agency for the Safety of Medicines (ANSM) to find more research into the issue. ANSM investigated the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken Epilim during their pregnancies. The agency identified that nearly half the children were born with some sort of defect, and thus could be classed as suffering from foetal valproate syndrome. Tragically, they discovered hundreds of stillbirths to mothers who were taking the drug.

When the results of study has resulted in the families of those affected by the adverse effects of sodium valproate to formed a class action in order to jointly make claims for birth defects due to taking Epilim. The families claim that Sanofi did not do enough to adequately inform the medical profession of the risks associate with the drug. It also claims the drug manufacturer failed to put adequate warning on its packaging to inform mothers-to-be about the potential risks.

In Ireland, the Disability Federation has called on the government to conduct an audit of children diagnose with foetal valproate syndrome. The organisation claims the scale of the problem in Ireland should be identified in order that adequate support measures are provided for families. If a member of your family has been affected by foetal valproate syndrome, and you would like to know more about claims for birth defects due to taking Epilim while pregnant, you should speak with a solicitor.