The 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 Depakine – an anti-epilepsy drug that has been available in Ireland since 1983 under the trade name Epilim. Epilim contains an active ingredient – sodium valproate – that stabilises electrical activity in the brain and has therefore also been prescribed for bipolar disorder, migraine and other chronic pain conditions.
When taken by pregnant mothers, the risk exists that the sodium valproate will be absorbed as valproic acid in the bloodstream and affect the health of their unborn child. In Ireland, children born after being exposed to valproic acid can 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 – where Depakine had been prescribed since 1967 – but no formal announcement was made to the medical profession by Sanofi until 2006. Even then, few medical professionals were aware of the side effects until France´s social affairs inspectorate – IGAS – investigated valproate birth defect claims in the Rhone-Alpes region last year.
IGAS´ research revealed that around 450 babies in the region had been born with congenital defects between 2006 and 2014 after being exposed to valproic acid. 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, and also promoted a much deeper study of the risks 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, and they 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.