NHS England has sent out a letter to all women and girls in England aged 12-55 who are currently prescribed sodium valproate. The letter contains important information and reminders of safety considerations, including advice on contraception and pregnancy, and encourages regular treatment reviews.
What is sodium valproate?
Sodium valproate is an effective antiepileptic drug (AED) which can also be prescribed for bipolar disorder and migraines. The drug is no longer recommended for women of childbearing age unless they are on a Pregnancy Prevention Plan, due to new guidelines by the European Medicines Agency. Evidence from research funded by Epilepsy Research UK over the last decade was central to these guidelines. This research was one of several important initial studies that led to the understanding that using sodium valproate during pregnancy carries a 4 in 10 risk of developmental disorders and roughly a 1 in 10 risk of birth defects.
What does the letter say?
The letter, which has been sent to around 20,000 women and girls in England this month, urges women to continue taking valproate medication unless they have spoken with their epilepsy doctor or nurse. It outlines the potential risks of valproate in pregnancy and reminds women and girls taking the AED to make an appointment with their doctor if:
-They have not had a treatment review in 12 months
-They are pregnant or if they want to try for a baby
-They are not using contraception that has been specifically recommended for use alongside sodium valproate (ideally a coil or an implant).
You can read the full letter here.
Why has this letter been sent?
The letter is one of several initiatives by the clinically-led Valproate Safety Implementation Group (VSIG) to inform patients and support healthcare providers around the safe prescribing and management of valproate. The group was established following the release of the Cumberlege (First Do No Harm) Review, which responded to patient concerns about side effects from NHS treatments, including sodium valproate. The VSIG is implementing the recommendations of the review, which concluded that wider change is required to optimise maternal and foetal health in pregnancy.
You can read more about the Valporate Safety Implementation Group and their programme of activity here.
Read Dr Rebecca Bromley’s Research Blog in response to the publication of the Cumberlege Review here.