Government strengthens warnings around sodium valproate
It has also endorsed the government's advice that all women who are taking sodium valproate should have regular reviews of their treatment.
Sodium valproate is recognised as one of the most effective drugs for treating people with idiopathic generalised epilepsy.
But it can also be associated with a risk of birth defects and problems with early childhood development in children born to women who take the drug during pregnancy.
Up to 4 in 10 babies of women who are prescribed sodium valproate during pregnancy are at risk of problems with learning and development and 1 in 10 are at risk of birth disorders.
New toolkit around sodium valproate
As knowledge of these risks has increased, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a new toolkit to make sure all women are aware of the dangers and, with their healthcare professional, can make informed decisions around their treatment before, during and after pregnancy.
The toolkit, aimed at both women and children with epilepsy and healthcare professionals, includes:
- a credit-card-sized patient card to be issued by pharmacists
- booklets for healthcare professionals and patients, with a checklist of key questions and discussion points to be kept with the patient's notes.
Better labelling is also to appear on the packaging of sodium valproate medicines later this year. Sodium valproate is prescribed as Epilim, Depakote and other generic brands.
Dr Sarah Branch, deputy director of MHRA's vigilance and risk management of medicines division, said: 'The warnings on the risks of valproate in pregnancy were strengthened last year. We want to ensure that women and girls have the latest information about the risks of developmental disorders and birth defects in children exposed to valproate during pregnancy. This toolkit supports healthcare professionals to give that advice to their patients.
'It is important no-one should stop taking valproate without discussing it first with their doctor. If valproate is the only treatment option, women of childbearing age should be given effective contraception. Women taking valproate must have regular reviews of their treatment.'
Matthew Sowemimo, director of external affairs at Epilepsy Society said: 'This toolkit should help to ensure that awareness of the conception-related risks of taking valproate is heightened among women with epilepsy, while reinforcing to healthcare professionals that preconception counselling is an essential part of their treatment.
'The MHRA has worked with a number of stakeholders to create detailed guidance for healthcare professionals and their patients, while confirming that valproate remains a very effective treatment for a number of people with epilepsy.'
Sodium valproate may be only treatment
Professor Ley Sander, medical director at Epilepsy Society, emphasised that for some women, sodium valproate may be the only drug that will control their seizures and that this was one of the challenges for healthcare professionals in managing the treatment of girls and women of childbearing age.
He said: 'Seizures are not benign events. In some circumstances, tonic clonic seizures may cause miscarriages, trauma related to falls and blood conditions that can affect the developing baby.
'The risk of sodium valproate has to be assessed against the risk of seizures to both mother and baby.
'Under no circumstances should a woman suddenly stop taking her drugs without consulting her GP or neurologist. Preconception counselling is vital.'
Making sure risks are known
Matthew Sowemimo said that Epilepsy Society would continue to work with the MHRA to ensure that every woman who is prescribed sodium valproate as an anti-epileptic drug is fully aware of the risks involved.'
Read Epilepsy Society policy advisor Finn O'Dwyer-Cunliffe's blog on the issues around sodium valproate.