Sodium Valproate FAQs
- What is sodium valproate?
- What are the brand names of valproate medicines?
- What is Epilepsy?
- What are the concerns arising from the use of sodium valproate?
- How long have there been concerns about the taking of sodium that operate while pregnant?
- What did the original product licence state in 1974?
- What is the latest advice about taking sodium valproate?
- What are the potential consequences of taking sodium valproate while pregnant?
- Should I stop taking sodium valproate?
- What is the response from a manufacturer of sodium valproate?
- Is it possible to make a claim for birth defects arising out of the use of sodium valproate?
- I took sodium evaporate many years ago. Is it still possible to bring a claim for compensation?
Sodium valproate medication is used to treat seizures. Epileptic seizures are recurrent and can be unprovoked. Sodium valproate works by reducing abnormal electrical activity within the brain.
The medication has been used successfully over many years, to treat those with epilepsy and bipolar disorder. Indeed, over 90% of women with epilepsy go on to have healthy babies.
- Micropakine LP
Epilepsy is seizures which come about as a result of abnormal brain activity, when the electrical signals travelling through the brain become disrupted. There are two types of seizure, generalised tonic-chronic seizures and partial seizures. Epilepsy is frequently controlled by anticonvulsants medication, such as sodium valproate.
Sodium valproate has been used successfully over many years to treat patients with epilepsy and bipolar disorder. However, there is evidence to indicate that taking sodium valproate while pregnant may cause birth defects. Furthermore, it is suggested that those birth defects can be passed on to the next generation.
The use of sodium valproate has been linked to 20,000 cases of catastrophic disabilities in children in the UK. Norman Lamb, MP, has referred to the situation as an “extraordinary scandal”.
According to the Epilepsy Society 7 women in 100 (7%) who are prescribed sodium valproate had a baby born with a major malformation. This figure rises to 1 in 10 women (10%) if they took more than 1000 mg per day. Furthermore, up to 40% of mothers who took this medication have children who have difficulties with development and learning.
The evidence suggests that even at the time of licensing this medication, back in 1974, there were concerns about the possible side effects. Those concerns continued to grow over the following years, but is only relatively recently, in the last couple years, that action has been taken to raise awareness about the risks of taking sodium valproate while pregnant.
The original product licence stated, “In women of childbearing age, it should only be used in severe cases or those resistant to other treatments”.
On 24 April 2018 the Medicines and Healthcare Products Regulatory Agency (MHRA) issued a statement stating, “Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP)”. Additionally, the MHRA recommended women currently taking the medication should seek a review with their doctor.
The National Institute for Health and Care Excellence (NICE) 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 following symptoms have been identified as arising out of taking sodium valproate while pregnant:
- speech delay
- joint laxity
- glue ear
- spina bifida
- behavioural difficulties
- attention deficit hyperactivity disorder (ADHD)
- neural tube defects
- cleft palate
- developmental problems-delayed walking, delay talking
- memory problems
- lower intellectual ability
- malformations of the face
- malformations of the skull
- heart problems
- respiratory issues
- noise sensitivity
- sensory issues
- autism spectrum disorders
- social anxiety disorder
- malformations of the kidney
- hare lip
- cerebral palsy
- curvature of the spine
- deformities from the bladder to the penis
No. You should take medical advice if you have concerns about the medication you have been prescribed. Indeed, the Medicines and Healthcare Products Regulatory Agency (MHRA), in April 2018, recommended those taking sodium valproate to seek a review with their doctor as soon as possible. They made clear that no one should stop taking the drug without medical guidance.
Sanofi (a manufacturer of sodium valproate) stated in 2017 that they “sincerely empathise” with families affected. Importantly, they acknowledged the increased risks of physical and cognitive problems when using sodium valproate in pregnancy.
It is possible to make a claim for compensation arising out of the use of sodium valproate while pregnant. Either the parent of a child who has been born with birth defects can make the claim on behalf of the child, or if the child is now an adult, they can make a claim for compensation.
There are time limits for bringing compensation claims but where knowledge as to the cause of the birth defect has only recently become known it may still be possible to bring a claim for compensation after 20 or 30 years, or perhaps longer, bearing in mind important information about the possible side effects was kept hidden from mothers to be, from the time the product was being licensed.
There have also been calls for the government to set up a compensation fund (as has been done in France), although as at the summer of 2018 the government have not responded to such a request.
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