Birth Defect Claims against Sanofi made in France

by | Apr 21, 2017

Parents whose children were exposed to valproic acid in the womb have started making birth defect claims against Sanofi – the French manufacturer of Epilim.

Epilim is the trade name in Ireland for an anti-epilepsy drug (Depakine) introduced into France in the 1960s. Epilim contains sodium valproate and has also been prescribed to treat bipolar disorder, migraine and other chronic pain conditions because of an agent in valproate called GABA that stabilises electrical activity in the brain.

When taken by woman during pregnancy, the sodium valproate is broken down into valproic acid which – when it enters the bloodstream – can have an adverse effect on the health of the unborn child. Children born with “foetal valproate syndrome” have been known to suffer from a range of congenital and development issues including autism and spina bifida.

The risks of foetal valproate syndrome due to taking Epilim during pregnancy were first identified in the 1980s, but the evidence was considered not sufficiently conclusive and was allegedly covered up to prevent “fruitless anxiety”. Sanofi, the manufacturer of Epilim, later informed the medical profession of the risks in 2006 but in a manner that left many medical professionals in the dark.

Only recently has France’s National Agency for the Safety of Medicines (ANSM) looked deeper into the birth defect claims against Sanofi, and the agency has just published a report revealing that up to 4,100 children were born between 2007 and 2014 with “severe malformations” due to their mothers having taken the French version of Epilim. Hundreds more died in the womb.

The report has prompted the children´s parents to form a class action making birth defect claims against Sanofi on the grounds that the drug manufacturer failed to adequately advise the medical professional of the risks associated with Epilim or print warnings on the outside of the packets. The French government has also got involved and is discussing a compensation package.

In Ireland, Epilim is still sold without a warning on the front of the packet, and it is not known how many children have been diagnosed with foetal valproate syndrome due to being exposed to valproic acid in the womb. If a family member has been affected by this issue, and you would like to know more about birth defect claims against Sanofi, please do not hesitate to speak with a solicitor.

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