A class action comprising several hundred sodium valproate side effect claims has begun in France to compensate children who sustained injuries in the womb.
Sodium valproate is an active ingredient of the drug known in Ireland as Epilim. In 1983, Epilim was introduced into Ireland after having been successfully used in France for treating patients for epilepsy and bipolar disorder. The drug was also prescribed in Ireland to treat migraine because it stabilises electrical activity in the brain.
Sodium valproate breaks down in the bloodstream and is absorbed as valproic acid. If taken by pregnant women, the valproic acid can enter the womb and have an adverse effect on the development of the foetus. Children exposed to valproic acid in the womb have been born with a wide range of development issues including spina bifida and autism.
Allegedly, the sodium valproate side effects were suspected before Epilim was introduced in Ireland but, due to the limited studies that had been conducted on the foetal development issues, the information available at the time was considered to be inconclusive. However, France’s National Agency for the Safety of Medicines (ANSM) has now looked deeper into the issue and produced a disturbing report.
In the preparation of its report, ANSM researched the health of 8,701 children born between 2007 and 2014 whose mothers had taken the French-branded equivalent of Epilim during pregnancy. The agency identified up to 4,100 children suffering from sodium valproate side effects along with hundreds of stillbirths attributable to the active ingredient.
ANSM´s report has prompted hundreds of sodium valproate side effect claims that have been combined to make one large class action against the manufacturer of Epilim – Sanofi. The sodium valproate side effect claims are currently being made on behalf of children in France who have been diagnosed with foetal valproate syndrome, but is likely to expand across the world.
In Ireland, there are no records relating to children who have been diagnosed with injuries due to foetal valproate syndrome, and a support group for parents – the FACS Forum – has called upon the government to conduct an audit to identify the scale of the problem. The support group hopes the audit will result in support being provided for parents of children suffering from sodium valproate side effects.
For further information about what support is currently available for children exposed to valproic acid in the womb, the FACS Forum can be reached via the disability-federation.ie website. If you would like to find out more about the sodium valproate side effect claims being made in France, you should speak with a solicitor.