‘First Do No Harm’, the report of the Independent Medicines and Medical Devices Safety (IMMDS) Review into the use of sodium valproate in pregnancy (and two other controversial treatments) has now been published. Its findings are highly critical of the healthcare system’s treatment of women who were prescribed the drug, which their doctors knew could severely injure their unborn babies. Over the 40+ years since the drug was released, doctors’ moral and legal duty to inform and involve women in their choice of treatment has increased, but valproate is still being prescribed to women of childbearing age without adequate warnings. The report criticises the healthcare system’s failure to follow up those treated with valproate and apparent lack of concern over its devastating side effects. It estimates that 20,000 babies may have been affected by exposure to valproate in pregnancy. What is sodium valproate? Sodium valproate is a highly effective drug treatment for epilepsy and bipolar disorder. In the UK, 27,000 women of childbearing age are currently prescribed valproate. Valproate is known by its brand names, such as Epilim, Episenta and Depakote. Valproate was first licensed in the UK in 1972 for the treatment of epilepsy. At that time, the manufacturers acknowledged to the licensing authorities that valproate had been shown to cause birth defects in studies on animals. Over time, doctors were made aware as increasing evidence emerged of the drug’s damaging physical and neurodevelopmental effect on the unborn babies of women who had taken valproate during pregnancy. Drugs which cause malformation or injury to the developing fetus (unborn baby) are called teratogens. Reports of valproate’s teratogenic effect on the physical development of unborn babies increased during the 1980s. These included Fetal Valproate Syndrome and neural tube defects (such as spina bifida). In the early 2000s, doctors received further information about valproate’s neurodevelopmental effect on unborn babies, including developmental delay, reduced IQ and autism. Valproate is now known to expose unborn babies to a 10% risk of serious birth defects and 40% risk of developmental disability. Times have changed since 1972, when the risks of medicines were not directly accessible to patients who relied on their doctors to balance the risks and benefits of the treatments they prescribed. Until 1994, there was no legal obligation to include information about risks in the patient information leaflet provided with the drug. However, by 2004 the NICE guidelines made it clear clinicians (doctors) had a responsibility to give women and girls accurate information and counselling, according to their individual needs, so that they could make informed decisions about their treatment. Despite repeated efforts to ensure that doctors properly inform women of childbearing age about the risks of pregnancy whilst taking valproate, finally leading to a change in valproate licensing regulations and the Pregnancy Prevention Programme (PPP) in 2018, the review found that women are still becoming pregnant whilst on valproate without any knowledge of the risks. This echoes the recent research findings of epilepsy charities, suggesting that many women taking valproate medication are unaware of the risk. The review estimates that hundreds of babies each year are still being born after exposure to valproate. IMMDS Review – valproate conclusions and recommendations ‘First Do No Harm’ is a very comprehensive report into the failings of the healthcare system as seen through the treatment of patients and response to their concerns in three key areas of care. Whilst each patient’s own treatment and injury will have been different, the review’s general findings in relation to valproate included: Sodium valproate was known to be teratogenic to animals when it was licensed but no long- term follow-up took place at that time. There was a delay between doctors becoming aware of the valproate risk of physical malformations and neurodevelopmental effects on unborn babies and warnings being given to patients. The entire healthcare system was too slow to respond to emerging information, either with warnings, regulatory action or by commissioning further research and to take action to ensure that women were aware and were being properly advised. Many women were not given enough information about the risks and benefits of their epilepsy treatment and family planning options to make informed decisions. Patients’ concerns were dismissed by their doctors or they were reassured that the drug was safe or that any concerns with their babies could be ‘fixed’. It took the healthcare system over 40 years to put in place measures to ensure that women were fully informed of the risk before becoming pregnant. Despite the requirements of the Pregnancy Prevention Programme (PPP) hundreds of women are still becoming pregnant on valproate while unaware of the risks. Those who have suffered avoidable harm are due an apology and should receive support. Those affected are not receiving adequate support. Specialist centres should be set up for families affected by teratogenic medication to provide integrated medical and social care expertise so that they can access the services they need in one place. NHSE&I (NHS England and NHS Improvement) should write to all women and girls (on valproate) of childbearing potential asking them to see their GP or specialist to ensure their treatment complies with the PPP. An ex gratia scheme, paid for by the government and the manufacturer, should be set up to provide need-based payments to help those affected. The government should set up a redress agency to enable those who have suffered avoidable harm to claim compensation. Litigation (making a claim through the courts) remains an available option. Have you or your child suffered avoidable harm from being prescribed valproate in pregnancy? If you were prescribed sodium valproate but were not told of the risks to your unborn child at a time when your doctor had a duty to discuss the risks and your choice of treatment with you, your child may be entitled to claim compensation for their physical or neurodevelopmental disability. Do not wait to be contacted by the NHS. The review makes it clear that the healthcare system doesn’t know how many people its valproate negligence has affected. Boyes Turner’s clinical negligence team are highly experienced in recovering substantial compensation for children and young adults who have suffered severe physical and neurological disability at or around the time of birth. Compensation cannot turn back the clock, but countless clients have found that compensation can provide a lifeline to essential care, therapies, equipment and support, educational assistance, adaptations to accommodation and ease the financial hardship associated with caring for a disabled child. If you are caring for a child or young adult who has suffered physical or neurodevelopmental disability as a result of negligent valproate exposure in pregnancy, contact us by email at mednegclaims@boyesturner.com
