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Lawyers for drug victims welcome announcement from MHRA on epilepsy drug ban for pregnant women

Lawyers welcome ban on epilepsy drug Sodium Valproate for childbearing women who are not taking part in a pregnancy prevention programme

Posted on 24 April 2018

Law firm Leigh Day, which acts on behalf of campaigners for those affected by the epilepsy drug Sodium Valproate, have welcomed the news from the Medicines and Healthcare Products Regulatory Agency (MHRA) of a ban on the prescription of the drug in the UK for all women of childbearing potential who are not enrolled in a pregnancy prevention programme.
The MHRA announcement made today also indicates that the warnings on the  packaging of the drug, known by its brand name Epilim, will be updated and that the drug will be prescribed in monthly quantities to encourage closer medical supervision of prescription.
The news from the MHRA comes within a week of a submission by campaigners, including OACS Charity and FACSaware, to Baroness Cumberlege ahead of a Government ordered review she is to chair into the effects of the drug.
The formal submission to the ‘Cumberlege Review’ was made on behalf of leading campaign groups OACS Charity and FACSaware by Leigh Day.
The Review is intended to examine the extent to which the current regulatory regime for medical products, both drugs and devices, is fit for purpose.
In announcing the Review, The Secretary of State for Health Jeremy Hunt, identified three focal issues; Sodium Valproate, Vaginal Mesh and Primodos.
Leigh Day have worked with OACS Charity and FACSaware along with leaders in the field of product liability and regulatory law,  in order to provide Baroness Cumberlege with a substantive document that makes the legal case for a government sponsored Public Inquiry into the regulatory and legal failings exposed through the history of Sodium Valproate prescription in the UK.
The submission also calls for a bespoke Compensation Fund to be set up to provide financial support for the thousands of individuals who have suffered birth defects as a result of their in utero exposure to Sodium Valproate.
Sodium Valproate is a highly effective anti-convulsant drug, prescribed to control epileptic convulsions. Marketed by pharmaceutical giant Sanofi and better known as Epilim, the drug was first licensed for use in the UK in 1973.
Campaigners have long identified an alleged ‘Information Gap’ between what patients were told about the teratogenic capacity of the drug between 1973 and 2005, and what research, regulators and Sanofi allegedly knew but chose not to include on Patient Information Leaflets.
In particular, campaigners highlight the allegedly misleading packaging for Epilim which failed to identify the need for pre-pregnancy counselling; and the now indisputable fact of the many fold increased risk of a cluster of congenital abnormalities known as Foetal Valproate Syndrome, or FVS.
It is estimated that around 20,000 individuals are affected by FVS in the UK and that FVS was and is, in most cases, an injury that could have been avoided.
The 120 page submission, drafted by Leigh Day on a pro bono basis, along with a team of legal and clinical experts, highlights the fact that the parents whose children have been affected by FVS suffer a ‘Double Disability’; that is the fact of their own epileptic condition plus the need to care for their children many of whom, it is argued, have been severely disabled as a direct result of their in utero exposure to Epilim.
Despite the fact of that ‘Double Disability’, and the alleged culpability of Sanofi and the UK regulator, to date the vast majority of FVS sufferers and their families have been denied access to justice and denied access to a compensation fund to assist with the complex health care needs suffered by the children and young people affected by FVS.
The submission from the campaigners urges Baroness Cumberlege to ensure that these families are finally given a voice and the compensation that they so desperately need.
Zahra Nanji of the Consumer Law and Product Safety Department Leigh Day, commented:
“OACS Charity and FACSaware represent parents and carers who have campaigned tirelessly for more than 40 years to achieve justice for their children and better labelling of the drug Epilim in order to safeguard other women and children from FVS.
“To date, that campaign has proved effective in improving the clarity of product warnings for Epilim as evidenced by the MHRA announcement today, but their demand for answers as to how and why Epilim was released on to the UK market without appropriate labelling in the first place; and why they have had no financial support from Sanofi or the UK government; remain unanswered.
“We very much hope that Baroness Cumberlege’s Review will recommend that a Public Inquiry should take place into Sodium Valproate prescription in the UK along with a compensation fund for all those affected.
“We believe that the history of Sodium Valproate prescription in the UK exposes the dangerous failings at the heart of our existing regulatory system in the UK, which unfortunately are not confined to the past but continue to expose individuals to potentially defective products, as seen more recently through the metal on metal hip scandal, for example.
“These families have waited long enough; we believe that the political reality of Brexit may well offer the UK government a unique opportunity to improve UK medical product regulation and ensure that the British public are better safeguarded against medical product injuries, including FVS.”
For more information about the submission and the charities involved please email valproate@leighday.co.uk or go to the OACS Charity and FACSaware websites.