Changes to way valproate is prescribed
New measures to affect both men and women
We have been advised by the medicines regulator – the MHRA – that there are to be some important changes made to the way that valproate is prescribed. This will affect both men and women under the age of 55 and girls of childbearing age.
The changes follow a review of safety data relating to valproate (Epilim, Depakote and other generic brands*). This included data that showed valproate was still being prescribed for some women and during some pregnancies, as well as evolving information about potential risks in men.
It is important that anyone currently taking valproate should continue to take their medication as prescribed. You will be contacted by your doctor to discuss any changes that need to be made. There is no need for you to do anything right now.
Current regulations around valproate
Because of the risk of birth abnormalities and neurodevelopmental disorders following exposure to valproate during pregnancy, women and girls under the age of 55 can only be prescribed the medication if a Pregnancy Prevention Programme is in place, including the use of an effective contraception.
Valproate should only be considered if all other treatments have proved ineffective or have not been tolerated.
Until now, regulations around valproate have not included men with epilepsy.
New measures around valproate
Women and girls under the age of 55 must still only be prescribed valproate if a Pregnancy Prevention Programme is in place, including the use of an effective contraception.
However, new measures have now been introduced to include both men and women.
Men and women under the age of 55 should not be prescribed valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment.
Where possible, both men and women who are already taking valproate should be switched to another treatment unless two specialists independently consider and document that there is no other effective or tolerated treatment or the risks do not apply.
Why do the new measures include men?
Since 2011 a possible risk of impaired fertility in males has been included in the product information. This states that some animal studies show adverse effects of valproate on the testes of juvenile animals as well as transgenerational effects.
The MHRA does not know what this means for humans as it’s not always possible to be sure that an effect seen in animals will be the same in a person taking a medicine.
There is currently limited data available on these risks and further studies are planned. There is also an ongoing retrospective study on the outcomes of babies exposed to valproate via paternal use.
Who conducted the review of data around valproate?
The review of available data around valproate was conducted by the MHRA – the Medicines and Healthcare products Agency. This was then considered by the Commission on Human Medicines – the CHM – who made safety recommendations around future prescribing of the drug.
Why do the changes only apply to people under the age of 55?
The CHM has advised that their measures apply to people under the age of 55 because this is the age-group evidence suggests is most likely to be affected by the risks of valproate when taken during pregnancy and by the possible risk of impaired fertility in males. Impaired infertility is thought to be reversible upon dose reduction or discontinuation and should be discussed between patient and doctor as part of the informed consent process.
When will the changes come in?
As of today, doctors are advised to avoid starting people newly diagnosed with epilepsy on valproate, but to consider safer alternatives. They are also reminded that women and girls should only be prescribed the medication if a Pregnancy Prevention Programme is in place.
The MHRA will be providing more details about how the changes will be implemented shortly and we will bring you updates here.
It is important that anyone currently taking valproate should continue to take their medication as prescribed, as not doing so can be life-threatening.
* Valproate is also known as Epilim, Depakote, Convulex, Episenta, Epival, Kentlim, Orlept, Sodium Valproate, Syonell, Valpal, Belvo and Dyzantil.
Update on MHRA review into safe use of valproate