What is Valproate?
Sodium valproate is an anti-convulsant drug which is used to reduce fits or seizures in people with epilepsy. It has many trade names, including Epival and Epilim. Valproate is also prescribed to stabilise people who suffer from bipolar disorder.
Valproate is known to be dangerous if taken in pregnancy as it can cause serious long-term injury to the unborn baby. Since its introduction in 1974, the manufacturers’ product information for doctors has warned that valproate carries a risk of causing birth defects.
Doctors and pharmacists have always been required to take extreme care in prescribing valproate drugs to women of childbearing age but there is extensive evidence of women being prescribed valproate without adequate steps being taken to ensure they do not become pregnant or warn them of the risks.
In 2018, doctors were banned from prescribing sodium valproate to women of childbearing age. In exceptional cases where no other equivalent drug is effective in managing the woman’s epilepsy, valproate must be prescribed in compliance with strict safeguards set out in the valproate licensing regulations and NICE summary guidelines. These include processes for warning the patient of the risks of valproate in pregnancy, and mandatory contraception via a pregnancy prevention programme (PPP).
Fetal Anti-Convulsant Syndrome (FACS) is a serious condition in which a baby suffers physical and/or developmental disability from his mother taking sodium valproate medication in pregnancy.
Babies who are exposed to valproate drugs, such as Epilim and Epival, have up to 40% risk of injuries which range from minor physical malformations to severe disability from spina bifida, organ defects, learning disability and autism.
Prescription of sodium valproate drugs to women of childbearing age is currently banned in most circumstances, owing to the high risk of serious injury to the unborn baby. In exceptional circumstances where no other treatment is available to the woman, hospital doctors, GPs and pharmacists must comply with strict rules for warning the woman of the serious risks of pregnancy and protecting her from pregnancy whilst she is taking the drug.
Where a child is physically or developmentally disabled because their mother was negligently prescribed valproate drugs before or during pregnancy, or allowed to become pregnant whilst on the drug, they may be able to claim substantial compensation for their injury.
Important information for families considering a valproate injury claim.