Prescriptions of sodium valproate in England are continuing to drop since April 2018 in all patients, according to new information from the Medicines and Healthcare products Regulatory Agency (MHRA) published today.
According to the new report, the overall proportion of women and girls prescribed sodium valproate fell by 56% between January-March 2018 and April-June 2024. New prescriptions in those aged 16-44 years old fell by 77%.
Just under a third (29%) of women and girls in that age group, who were prescribed valproate for epilepsy before May 2018, switched to lamotrigine or levetiracetam without then switching back to valproate.
This fall reflects the changing guidelines from the MHRA since 2018 in the prescription of sodium valproate in women, as it is known to cause risks to unborn babies if taken during pregnancy.
During the same timeframe, the overall proportion of males prescribed sodium valproate fell by 14%. However, new prescriptions in males aged 16-44 fell by 78%, with a lot of this (63% drop in new prescriptions) happening after the introduction of new safety measures in November 2023.
These safety measures advised that men, as well as women, under the age of 55 would need two specialists to independently agree that sodium valproate is the only medication that would work for the person, in order to have it newly prescribed. Women would also need to be part of a pregnancy prevention programme and sign an annual risk assessment form.
Men already taking the medication could continue to take it.
These guidelines followed findings suggesting sodium valproate could affect fertility in men. However, a recent, large, international study has thrown this into question, finding that sodium valproate has a ‘minimal’ effect on male fertility, and urging for more research on this.
The new report also found that around one in five men (19%) aged 16-44 taking sodium valproate for epilepsy before February 2024 switched to either lamotrigine or levetiracetam without switching back.
“No one left without effective treatment”
Alison Fuller, director of Health Improvement and Influencing at Epilepsy Action, said: “While we welcome this report highlighting the decrease in the number of valproate prescriptions for both men and women, concerns remain about the impact of restricting access to what for many people remains an effective medication.
“We note that the report does not provide information about the outcomes of the men and women who have moved from valproate onto a different medication. It is vitally important that the impact of the withdrawal of valproate is monitored, and that it remains available for those people for who it is the only medication that works to control their seizures.
“People with epilepsy must be at the heart of these decisions, with access to clear information and support. We also urge the MHRA to ensure that monitoring goes beyond prescription rates to include outcomes for patients, so that no one is left without effective treatment.”
The MHRA used Clinical Practice Research Datalink (CPRD) to access prescription data and carry out the evaluation. It said this is representative of the UK general population, but other data sources are available for monitoring sodium valproate prescribing too, such as prescribing in pregnancy.
The MHRA will continue to monitor prescriptions, publishing updates every six months.
More articles
