Families in France are seeking compensation for Epilim birth defects after a report linked the drug to thousands of child congenital and development issues.
Epilim has been prescribed in Ireland since 1983 to treat epilepsy, bipolar disorder, migraine and several types of chronic pain. First introduced in France in the 1960s under the brand name Depakine, Epilim has an active ingredient – sodium valproate – that stabilises electrical activity in the brain.
Over the past fifty years, it has been claimed that taking Epilim while pregnant can result in new-born babies suffering foetal valproate syndrome – a condition that can manifest as autism, cleft palate, spina bifida, a heart or kidney defect, a physical deformity or development issues.
Now research conducted by France’s National Agency for the Safety of Medicines (ANSM) has confirmed the claims after monitoring 8,701 children born to women known to have taken Depakine while pregnant between 2007 and 2014 – approximately 0.2% of all child births in France during the period.
The research identified up to 4,100 children were suffering “severe malformations” due to being exposed to the teratogenic nature of valproate in the womb – results that support a smaller study conducted by France´s social affairs inspectorate IGAS earlier this year.
The children´s parents allege the manufacturer of the drug – Sanofi – failed to place adequate warnings in packets of Depakine or advise medical practitioners of the possible side effects of sodium valproate, and have now started a class action in order to seek compensation for Epilim birth defects.
Although the manufacturer made an announcement about the risks of taking sodium valproate in 2006, a study two years later found that one in five doctors and one in three pharmacists (in France) were still unaware of the effects of sodium valproate on unborn children. Prescription rules were not tightened until 2014 and, in Ireland, Epilim is still sold without a warning in large type on the front of the packet.
If a member of your family has suffered a congenital or development issue due to not being informed about the risks of sodium valproate, several options exist to claim compensation for Epilim birth defects. It is recommended that you speak with a solicitor at the earliest possible opportunity to explain your personal situation and to find out what your options are.