The Medicines and Healthcare products Regulatory Agency (MHRA) has today announced that valproate medicines – used to treat epilepsy and bipolar disorder – must no longer be prescribed to women of child bearing age unless she is on a pregnancy prevention programme (PPP).
The medication significantly increases the risk of birth defects and developmental disorders in children born to women who take it during pregnancy. Up to 4 in 10 babies are at risk of developmental disorders, and around 1 in 10 are at risk of birth defects.
Healthcare professionals who prescribe valproate must ensure sure the women is enrolled in a PPP, which includes the completion of a signed risk acknowledgement form and seeing a specialist at least every year.
These new regulatory measures are being supported across the NHS with other authorities also making changes – such as new GP system computer alerts – to ensure changes in prescribing behaviour take place promptly. Women who are prescribed valproate are encouraged to contact their GP and arrange to have their treatment reviewed. Women should not stop taking valproate without medical advice.
Mr Edward Morris, Vice President for Clinical Quality at the Royal College of Obstetricians and Gynaecologists (RCOG), said:
“We welcome this action to reduce the risk of physical and developmental problems in children born to mothers who have taken valproate during pregnancy. Our clinical guideline on the management of epilepsy in pregnancy recommends that exposure to sodium valproate and other anti-epileptic drugs should be minimised by changing the medication prior to conception, as recommended by an epilepsy specialist after a careful evaluation of the potential risks and benefits.
“It’s important to note that stopping medication for long-term conditions completely or altering the dose can pose a serious risk to both mother and baby. Women are advised to seek advice from their GP and/or specialist team before conception or as soon as they are aware that they are pregnant. For women with epilepsy, the lowest effective dose of the most appropriate anti-epileptic drug should be prescribed and they should be looked after by a specialist team throughout pregnancy.”
Note to Editors
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RCOG Green-top guideline on epilepsy in pregnancy summarises the evidence on maternal and fetal outcomes in women with epilepsy (WWE). It provides recommendations on the care of WWE during the pre-pregnancy, antepartum, intrapartum and postpartum periods.
RCOG information for women on epilepsy in pregnancy.
About the RCOG
The Royal College of Obstetricians and Gynaecologists is a medical charity that champions the provision of high quality women’s healthcare in the UK and beyond. It is dedicated to encouraging the study and advancing the science and practice of obstetrics and gynaecology. It does this through postgraduate medical education and training and the publication of clinical guidelines and reports on aspects of the specialty and service provision. https://www.rcog.org.uk/