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 an anti-epilepsy drug that uses the active ingredient sodium valproate to control electrical activity in the brain. Introduced in France in 1967, Epilim was passed for use in Ireland in 1983, and is now also often prescribed to treat bipolar disorder, migraine and chronic pain.
At the time it was introduced into Ireland, claims for birth defects due to taking Epilim while pregnant were being investigated in France. It was alleged that the sodium valproate entered the bloodstream as valproic acid, which caused foetal congenital and development issues.
The evidence of birth defects due to taking Epilim was considered inconclusive, and the drug continued to be prescribed to pregnant mothers. It was only in 2006 that the manufacturers of the drug – Sanofi – warned 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 doctors and pharmacists were unaware of the risks associated with Epilim. 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 discovered.
France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the issue and researched the health of 8,701 children born between 2007 and 2014 whose mothers were known to have taken Epilim during their pregnancies. ANSM identified up to 4,100 children suffering from foetal valproate syndrome and discovered hundreds of Epilim-related stillbirths.
ANSM´s study has resulted in the families of those affected by the adverse effects of sodium valproate to form 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.
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.