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 Irish trade name of the French anti-epilepsy drug Depakine which is widely used to treat epilepsy. It uses the active ingredient sodium valproate to control electrical activity in the brain, and is also effective in treating bipolar disorder, migraines, and chronic pain. It was first introduced in France in 1967, and in the first concerns regarding birth defects in babies were made my medical professionals in France in the 1980s, it was introduced in Ireland under the name Epilim in 1983.
In the 1980s, 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. However, the evidence of birth defects due to taking Epilim was considered inconclusive, and the drug continued to be prescribed to pregnant mothers. It has been alleged that these claims were covered up to prevent any “unnecessary anxiety”.
It was only in 2006 that the French manufacturers of the drug – Sanofi – told leading medical professionals that they had evidence that sodium valproate may have adverse effects. They advised the medical profession to warn pregnant mothers of the potential risks of taking the drug.
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, and many pregnant mothers were still receiving the drug. 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. Furthermore, they discovered hundreds of Epilim-related stillbirth and cases of miscarriages.
ANSM´s study has resulted in the families of those affected by the adverse effects of sodium valproate to seek legal counsel. They 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.
In light of the French legal case, the Disability Federation in Ireland 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. Epilim’s label still does not carry a warning to pregnant mothers in Ireland. 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.