In January 2018, we wrote about the epilepsy drug, sodium valproate, which had been linked to 20,000 cases of catastrophic disabilities in children in the UK. At the time, MP Norman Lamb referred to the situation as an “extraordinary scandal”, and families affected were seeking compensation and an urgent public enquiry into the matter.
Much has changed in the past three months; drug regulators have now formally conceded the seriousness of the matter and have issued guidance to effectively ban the prescription of sodium valproate-based medication for those most likely to be affected.
What have the drug regulators now decided?
The Medicines and Healthcare Products Regulatory Agency (MHRA), the government agency tasked with regulating medicines and medical devices in the UK, issued a press release on 24th April 2018 stating, “Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)”. In addition, the MHRA have issued guidance recommending women currently taking valproate to seek a medication review as soon as possible from their doctor, making it clear that no one should stop taking the drug without medical guidance.
The National Institute for Health and Care Excellence (NICE), the government entity responsible for providing best practice information to the healthcare sector, has also updated its diagnosis and management clinical guidance for patients with epilepsy. The guidance now states, “Medicines containing valproate taken in pregnancy can cause malformations in 11% of babies and developmental disorders in 30–40% of children after birth. Valproate treatment must not be used in girls and women including in young girls below the age of puberty, unless alternative treatments are not suitable and unless the terms of the pregnancy prevention programme are met. In pregnancy, valproate is contraindicated, and an alternative treatment should be decided on, with appropriate specialist consultation”.
The controversy surrounding sodium valproate
Sodium valproate has been associated with thousands of disabilities in children as far back as the 1970’s. Unfortunately, many women taking the drug unwittingly put the health of their future children at risk as they were never informed of the dangers associated with the drug. In 2017, BBC News told the story of Emma Friedmann, whose son, who was 18 at the time of the article, had a range of severe impairments including autism, hearing and sight problems, and required full-time care. Ms Friedmann had been prescribed a sodium valproate drug which she took throughout her pregnancy. She said she was never warned of the risks to her or her baby.
There have been other cases reported of parents who have struggled to access the rehabilitation and therapeutic services their children so desperately deserve and need, including occupational therapy, physiotherapy, and speech and language therapy. As a result, parents have been left without access to the services and funding required to care for their children. Some relationships have collapsed under the strain of the situation, and due to the care demands placed on them, many parents are unable to work. The despair those in such predicaments have felt can only be imagined.
In 2017, the manufacturer, Sanofi, stated they “sincerely empathise" with the families affected, acknowledging there are increased risks of physical and cognitive problems when using sodium valproate in pregnancy. However, this expression of empathy is likely to be little comfort to anyone affected by this medication.
While sodium valproate does help those diagnosed with epilepsy manage their condition, this does not excuse the lack of clarity and openness regarding the risks to mothers and their unborn children.
Can I seek compensation if my child has been affected by sodium valproate taken during pregnancy?
For many families impacted by this drug, the financial ramifications can be immense. You may have lost considerable income due to either leaving your job or having to reduce your hours to become a carer to your child. And you may have faced considerable medical and related costs which have not been funded by your local authority or other government agencies, including having to modify your home for the needs of your child. If you are one of the many thousands of parents whose child has been affected by sodium valproate during pregnancy, you may have a case for financial compensation if your doctor did not warn you of the potential damage the drug could cause to your unborn child.
If you have been impacted by sodium valproate taken during pregnancy, call one of our specialist NHS and medical negligence solicitors today; we understand the immense physical, psychological and financial problems you are facing. We will take the time to listen to your situation in full and give you the benefit of our expertise in this area, in a manner that is highly empathetic and supportive.
Our personal injury team, including medical negligence specialist Simon Pimlott, has the expertise and knowledge to advise and represent you if you wish to make a claim for personal injury following taking sodium valproate. To talk about how we might be able to help, please phone us on 0333 123 9099, email us at firstname.lastname@example.org or fill in our contact form. Any discussions you have with us will be in the strictest of confidence and handled with the utmost sensitivity.