A controversial epilepsy drug is to be banned among women and girls of a childbearing age unless they have a “pregnancy prevention programme” in place, health officials have said.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has changed the licence for valproate medicines, which can be provided to people with epilepsy to prevent seizures.
Children born to women who take the medication during pregnancy are at a high risk of birth defects or developmental disorders.
The use of valproate in pregnancy has come under intense scrutiny recently – the European Medicines Agency held a public hearing into medicines containing valproate and the drug also forms part of a government review into how the NHS responds to concerns over treatments.
Now Epilim, Depakote and generic brands of valproate medicines can no longer be prescribed to women who have “childbearing potential” – unless they have a pregnancy prevention programme in place, the MHRA said.
It said that the measure has been put in place to “protect public health”.
It added that four in 10 babies born to mothers who take the drug during pregnancy are at risk of developmental disorders, and one in 10 is at risk of birth defects.
The new measures will mean that women have their treatment reviewed by a specialist, at least annually.
Meanwhile, the MHRA said that all women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed.
But it stressed that no woman or girl should stop taking valproate without medical advice.
The new measures will also mean that the packs the drugs come in will be reduced in size and all valproate labelling will come with a warning image.
“Patient safety is our highest priority,” said Dr June Raine, director of MHRA’s vigilance and risk management of medicines division.
“We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.
“I would like to particularly thank the families involved in the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.”
Health Minister Lord O’Shaughnessy said: “Our priority is always patients’ safety, so I welcome this decision to take strong actions to protect women and children.
“The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.”
Commenting on the news, Clare Pelham, chief executive of the Epilepsy Society charity, said: “The most important change today is that every woman and girl of childbearing age who has been prescribed sodium valproate will be able to see her doctor every year to discuss the risks of this drug to an unborn baby.
“She will leave the discussion with an important written reminder of the risks if sodium valproate is taken during pregnancy.
“This means that she will be able to make informed choices about whether to plan a pregnancy and her future medical treatment.
“It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities.
“All credit to the brave women who have campaigned for decades. And to Jeremy Hunt for acting on that campaign and insisting the NHS must now learn from its failure to listen and act sooner in response to the concerns raised over many years and during many governments.”
The Royal College of Obstetricians and Gynaecologists recommends exposure to sodium valproate and other anti-epileptic drugs should be minimised by changing the medication prior to conception, as recommended by an epilepsy specialist after a careful evaluation of the potential risks and benefits.