Valproate: new restrictions introduced

[THE Medicines and Healthcare products Regulatory Authority (MHRA) has introduced further restrictions on the prescribing of valproate, to be phased in from this spring.

Valproate is approved in the UK to treat epilepsy and bipolar disorder. Because of the known risk of birth defects and neurodevelopmental disorders following use of valproate in pregnancy, valproate should only be used in women of child-bearing potential if a Pregnancy Prevention Programme is in place, which includes a requirement to use effective contraception. Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated.

The latest data on the use of valproate in England shows that in the six months to March last year the number of pregnant women prescribed had fallen to 17 compared to 68 women in the period from April to September 2018. Research found that the babies of those patients had an 11% risk of birth defects and a 30-40% risk of neurodevelopmental disabilities which can be permanent.

In light of concerns that the current regulatory requirements for safe use are not being consistently followed, the MHRA conducted a review of the available data and asked for advice from the independent Commission on Human Medicines (CHM), which has listened to the views of patients and healthcare professionals.

The CHM has advised that no one under the age of 55 should be initiated on valproate unless two specialists independently consider and document that there is no other effective or tolerated treatment. Where possible, existing patients 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.

The guidance stresses that no one should stop taking valproate without advice from their healthcare professional. q