Drug manufacturer Sanofi has issued a statement acknowledging the valproate birth defect claims being made against the company in a French class action.
The drug responsible for prompting the valproate birth defects claims is sold as Depakine in France (since 1967), and as Epilim in Ireland (since 1983). It is commonly known as an anti-epilepsy drug, but is also used to treat bipolar disorder, migraine and other chronic pain conditions. Epilim contains an active ingredient – sodium valproate – that stabilises electrical activity in the brain.
When taken by pregnant mothers, the risk exists that the sodium valproate will be converted to valproic acid. This is then absorbed into bloodstream and adversely affects the health of their unborn child. In Ireland, children born after being exposed to valproic acid have been known to suffer from spina bifida, autism and a range of congenital and development issues under the umbrella term “foetal valproate syndrome”.
The risks were first identified in France in the 1980s, over a decade after the drug was introduced. However, no conclusive evidence was found linking the drug to the children born with defects, so no formal announcement was made to the medical profession. After further investigations, Sanofi informed medical authorities of the risks of the drug in 2006. In spite of the announcement, very few medical professionals were made aware of the side effects until France´s social affairs inspectorate – IGAS – investigated valproate birth defect claims in a case study the Rhone-Alpes region last year.
IGAS´s research revealed just under 500 children born in the region had congenital defects exposed to valproic acid during the period between 2006 and 2014 after being. The report called for a warning to be printed on the outside of each box of Epilim advising pregnant women not to take the drug due to the serious risks to the foetus.
A much deeper study of the risks was conducted by France’s National Agency for the Safety of Medicines (ANSM). The results of that study were recently released following an investigation into the health of 8,701 children, born to women known to have taken Depakine while pregnant between 2007 and 2014. The results revealed that up to 4,100 children had been born with “severe malformations” and many hundreds more had died in the womb or been delivered stillborn.
Following the release of the study, Sanofi issued a statement in which the company said: “We are aware of the painful situation confronting the families of children showing difficulties that may have a link with the anti-epileptic treatment of their mother during pregnancy.” However, the statement has not satisfied parents of the children affected by the side effects of Epilim. They sought legal counsel, and together have started a class action of valproate birth defect claims to recover compensation for their children.
In Ireland, Epilim is still sold without a warning in large type on the front of the packet, and it is not known how many children have been born with birth defects due to being exposed to valproic acid. If a member of your family has been affected by this tragic situation, and you would like to know more about valproate birth defect claims, you should speak with a solicitor at the first possible opportunity.