Pregnant women who use the drug sodium valproate, which is an effective relief for epilepsy and bipolar disorder, are not being informed about the risk to their unborn child.
The drug, sold under brands such as Epilim and Depakote and current prescribed to 28,000 women, has a 40% chance of developing learning disabilities and autism in new-borns if their mothers were using the drug while pregnant. It also carries a 10% of physical abnormalities.
Karen Keely, from the support group Fetal Anti-Convulsant Syndrome, argued that not enough had be done to inform pregnant women of the risks involved in taking the drug. She said: ‘Measures have been taken ... but these have largely been tick-box exercises with little regard for delivering real change.’
She made such comments at a hearing at the European Medical Agency (EMA) in London on Tuesday, which invited EU citizens to share their experiences of certain drugs. The hearing, thanks to a recent survey by Epilepsy Society, found that 3 decades after the initial health risks of the drug were discovered, 68% of women in the UK had not had the risks explained to them.
The drug, produced by French multinational pharmaceutical company Sanofi, was linked to birth defects more than 3 decades ago but it wasn’t until recently that regulations and warnings about the drug have stepped-up. In the UK the requirement to have additional warnings on the outside of packets was only put in place last year.
Speaking at the EMA hearing, Eric Teo, who is in charge of drug safety at Sanofi, said that he ‘sincerely empathises’ with the affected families but that: ‘Everyone in the health care system has a role to play to ensure risks and benefits are properly understood.’
He also argued that: ‘Valproate is an important treatment that many women continue to rely on ... It should be acknowledged that there is a real dilemma faced by doctors and women who have no other alternatives to control their seizures.’
The French medical regulator ANSM requested that the EMA begin a review of valproate at the start of the year as 1,200 families in France prepare to sue the the company because of its perceived failure to adequately inform women of the risks involved.
A similar case occurred in the UK in 2010 for families affected in England and Wales. But, the case was dropped when funding was withdrawn by the Legal Services Commission, spelling an end to a 6-year-long preparation process.
The families signed statements promising not to sue in future, in exchange for Sanofi not trying to reclaim their substantial legal costs.
Many in the UK are eagerly watching the events unfold in France and the EMA will publish its findings by the end of this year.