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Sodium valproate prescription rules will change in the UK for both women and girls, and men and boys, from spring next year.
This will be the first time valproate prescription rules will apply to men and boys, and comes in light of a recent review of the latest safety data by the Commission on Human Medicines (CHM).
The Medicines and Healthcare products Regulatory Agency (MHRA) has announced changes to the way sodium valproate will be prescribed for anyone under the age of 55. These changes are due to come into effect in 2023.
The new rules state that no one under the age of 55 should be prescribed sodium valproate, unless two epilepsy specialists independently agree it’s the only suitable epilepsy medicine for them.
Anyone currently taking sodium valproate will need to have a review of their epilepsy treatment and ideally be prescribed a different epilepsy medicine, according to the MHRA.
People currently taking valproate are advised to continue taking their medicines as normal in the meantime. Stopping epilepsy medicines could put people at risk of increased or breakthrough seizures.
Why the change to prescription rules?
The MHRA have advised that patients do not need to take any action at this time. However, Epilepsy Action believes that anyone with urgent concerns about their treatment should speak to their epilepsy specialist.
There are already strict rules in place around the use of valproate for women and girls of childbearing potential because of the significant risks if taken during pregnancy. These include a higher chance of birth defects or learning disabilities in babies exposed to the medicine in the womb.
The MHRA have reminded healthcare professionals about these risks and the need to ensure that the current Pregnancy Prevention Programme measures are followed, as there are concerns that this is not being done consistently.
The MHRA has also highlighted that some research suggests there may be a risk of reduced fertility in men and boys. Animal studies also suggest there may be effects passed from animals taking valproate to their offspring and future generations, but researchers are not sure if this would be the same in humans as it is in animals.
Concerned about the challenges
Alison Fuller, director of Health Improvement and Influencing at Epilepsy Action, said: “While we welcome these new guidelines as set out by the MHRA to improve patient safety and reduce risks around prescribing valproate, we urgently need more detail on how they will work in practice and with ongoing monitoring.
“At a time when the NHS is under more pressure than ever, we are concerned about the challenges people with epilepsy will face in getting opinions from two different clinicians, particularly if valproate is the only effective drug in managing their seizures.
“The proposed new measures will also mean men with epilepsy under the age of 55 are required to undergo a full review prior to the prescribing of valproate. However, we are still waiting to understand the full body of evidence behind these restrictions and its potential impact.
“Patient engagement was a key recommendation in the Cumberlege report, yet we are concerned that these new guidelines have come without adequate consultation from people with epilepsy and how they will impact on people’s treatment.
“It is, however, vital that anyone taking valproate must continue to do so until they have had a conversation about their medication with their healthcare professional.
“In the meantime, we will be calling on the MHRA and NICE to ensure these new measures are appropriately implemented, managed, and monitored to ensure that people with epilepsy are able to make informed decisions in a timely and safe manner.”
The National Institute for Health and Care Excellence (NICE) is expected to review and update its treatment recommendations in February 2023.
There is more information on the gov.uk website.
People taking valproate are advised to continue taking their medicines as normal, unless advised otherwise by their specialist. Stopping epilepsy medicines could put people at risk of increased or breakthrough seizures.