New regulations/guidance have been introduced for the drug sodium valproate. This medicine is commonly used to treat epilepsy, bipolar disorder, and less commonly, migraine, under the brand names Epilim, Depakote, Convulex, Episenta, Epival, Sodium Valproate, Syonell, Belvo & Dyzantil.
However, it is associated with a higher risk of birth defects and developmental disorders in babies born to those who take the medicine while they are pregnant. Male patients taking valproate can experience infertility, which may be reversible after treatment is stopped or the dose is reduced for some patients. As a result, regulatory authorities have implemented new measures to ensure that the risks associated with sodium valproate are properly communicated to patients.
NHS South Yorkshire Integrated Care Board understand that these measures may cause some inconvenience for patients, particularly those who need to see a specialist for a review. We want to ensure that patients are fully informed about the risks associated with sodium valproate while also minimising any potential disruption to their care.
They would appreciate your feedback on how we can best support patients during this time. They are open to any suggestions you may have on how we can improve our communication and support for patients.
Please send any feedback or suggestions to Ric James, SY Integrated Pharmacy and Medicines Optimisation Programme Manager, at ric.james@nhs.net. If it is helpful for a member of the Pharmacy team to attend any future meetings to discuss the matter directly, please also contact Ric to make the appropriate arrangements.
New risk reduction measures
For males aged under 55 years who have not used valproate before and in female patients aged under 55 years, this medicine is now only to be used when two specialists have agreed that their condition does not respond to other treatments. Patients will be asked to complete a risk acknowledgment form when treatment is started, and female patients will receive an annual review with their specialist.
For patients currently taking this medication, all female patients will discuss continued use or a replacement medication at their next annual review, and if the medicine is to be continued the same agreement between two clinicians and risk acknowledgement form will be issued. We’re awaiting guidance to be released by MHRA regarding annual reviews of males.
Part of the risk acknowledgment form will ask the two specialists to consider if there are other treatments available or if risks of pregnancy do not apply, such as patients using effective contraception.
It is important that all patients attend reviews when required and ensure that completed copies of the risk acknowledgment form are returned to either their specialist or GP.
It is essential to note that if a patient does become pregnant while taking sodium valproate, they should not stop taking the medication without consulting their specialist first. Suddenly stopping the medication can cause a condition to worsen, including a risk of seizure in those being treated for epilepsy and an increased risk of relapse in those treated for bipolar disorder.
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