The Independent Medicines and Medical Devices Safety Review.
Following on from our overview article we take a closer look at the Reviews commentary of the use of Sodium Valproate in pregnancy, the evidence collated of the harm caused and the recommendations of the Review.
What is sodium valproate?
More commonly known by brand names sodium valproate is licensed to treat epilepsy and bipolar disorder and can be used for migraine prophylaxis and pain management. Since it was first licensed in the UK in the early 1970s evidence has been documented of the physical and neurodevelopmental problems experienced by children whose mothers were taking the drug during pregnancy.
Advice on the different effects of use of the medicine whilst pregnant grew over the next 40 years. Litigation was issued against the NHS and one manufacturer in the 1990s, only for legal aid to be withdrawn on the case pre-trial.
Finally, in 2016, following Europe wide reviews, the UK launched a valproate “Toolkit” providing patients and professionals with information to make informed choices about taking valproate whilst pregnant.
The Review heard from families who did not receive information about the risks of treatment with sodium valproate during pregnancy. This prevented women from making informed choices about their treatment and led to life-long impacts for their families.
‘I felt so guilty, I felt it was my fault for his problems and disability… not to be told what these tablets can do and have done to many families is terrible.’
‘If I’d been told my baby could be damaged by the medication, I was taking I would not have taken it. All our hopes and dreams were destroyed by this, but we love our son dearly. We weep for the child who could have been and the man who never was.’
The evidence showed a pattern of birth defects and developmental problems for children whose mothers took the drug whilst pregnant. Affected children have physical problems such as cleft palate, spina bifida, heart and limb defects. The development problems may show in language difficulties, intellectual disability, memory and behavioural issues, with some amounting to meeting the criteria for other diagnosis such as Autism, or Attention Deficit Hyperactivity Disorder.
Recommendations of the Review
- Continuing to improve communication of risks to ensure that all women on sodium valproate are aware of the risks prior to family planning decision
- Identifying all of those affected by exposure to sodium valproate in utero to ensure access to support.
- Establishing specialist centres for families affected by teratogenic medication.
- An ex gratia scheme to provide need-based payments to help those affected by valproate exposure. In our view both the government and Sanofi should contribute to this scheme.
- Long-term data collection of women on all antiepileptic drugs (AEDs) and their children.
- Measures to reduce and monitor effects of other medications which are regularly taken during pregnancy, and are considered to have teratogenic potential, or known risk above that of the general population.
If you or your firm are instructed on any of cases affected by the review and want to discuss how to fund these please get in touch.
Head of Consumer, Affiniti Finance
 Quotations from “First do no Harm Report “ The Independent Medicines and Medical Devices Safety Review, published July 2020