An insightful report was published yesterday that brings hope for those who suffered avoidable harm from taking sodium valproate during pregnancy.
In the Independent Medicines and Medical Devices Safety Review, Baroness Cumberlege provided nine recommendations to help those affected.
What is sodium valproate?
It is a medicine prescribed to individuals who suffer with epilepsy and is known in the UK by brand names, Epilim, Episenta and Depakote.
Evidence has emerged that use of the drug during pregnancy can have physical and neurodevelopmental effects on children. Of babies whose mothers take sodium valproate, up to one in ten are at risk of a birth defect and four in ten have problems with development and learning as they grow.
Use of the drug can also cause babies to be born with Foetal Valproate Spectrum Disorder (FVSD), a rare condition that is linked to exposure to valproic acid during the first three months of pregnancy.
Affected children have a higher chance of a cleft palate, spina bifida, heart problems and limb defects. They may also have minor physical difficulties, such as facial differences that give rise to a recognisable pattern, or bendy joints, as well as an increased risk of language difficulties, intellectual disabilities, memory, learning and behaviour problems. In some cases, the developmental difficulties they experience may meet the criteria for other diagnoses, such as Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder.
An absence of risk awareness
There is a body in place – the Medicines and Healthcare Products Regulation Agency – that is supposed to ensure all women who take sodium valproate for epilepsy are fully informed of the risks, advised on the importance of using contraception and invited for annual reviews of their treatment.
A survey undertaken this year found one in ten women currently taking the drug were unaware of the risks in pregnancy. It also discovered one in five didn’t know that it could also cause learning and developmental delays in children. Almost half of those consulted said they
had not discussed the risks of taking the medicine with health professionals in the last 12 months and just 41% had signed an Annual Risk Acknowledgement Form.
It is astounding to think that one in three women were unaware that valproate could cause birth defects and nearly half didn’t know about its potential for learning and development problems.
Preventing future harm
Baroness Cumberlege has said those who have been harmed by use of this drug are not only due an apology from the government, but also better care and support through specialist centres.
She also made several recommendations to reduce the risk of future harm, including setting up a prospective registry of all women on anti-epileptic drugs who become pregnant and mandatory reporting of data relating to them and their children, collated over lifetimes.
The report went on to suggest a new, independent Redress Agency for those harmed by medicine or medical devices should be created, based on models operating effectively in other countries. It would administer decisions using non-adversarial processes, focusing on systematic failings, rather than blaming individuals.
A new Quality Improvement Module, prescribing safety, was written into the Quality Outcomes Framework for 2019/20, which includes valproate and the pregnancy prevention programme. Baroness Cumberlege believes an indicator on safe prescribing in pregnancy should also be introduced for future iterations.
Her recommendations continue to state women should be able to access appropriate counselling relating to epilepsy treatment and contraceptive choices, whilst clinicians should continue to follow guidance on prescribing valproate and alternatives. Significantly, Baroness Cumberlege suggests an acknowledgement of risk form should be attached to the prescribing and/or dispensing of all medication considered to have teratogenic potential or a risk above that of the general population.
Due to failings in the system, women have been prevented from making informed choices about their treatment for epilepsy and family planning options. It is negligent to not advise a mother of the risks and refer her for specialist advice about her medication.
We can help those adversely affected by the side effects of sodium valproate obtain compensation and justice. For more information, contact our friendly, professional solicitors on (0114) 218 4000 or email: info@tayloremmet.co.uk
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