The controversial epilepsy drug sodium valproate must no longer be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place, under new rules.
The move, agreed across Europe, is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant while taking the drug that is linked to birth defects.
The measures follow years of campaigning for stronger action by charity’s and numerous attempts by regulators to beef up guidance and warnings about the potential risks linked to the drug.
- New toolkit on risks of valproate during pregnancy
- Reminder on valproate risk for pregnant women
- Nurse-led project helps women with epilepsy plan pregnancy
Despite the efforts to make the risks from the drug more explicit over the past few years, parents who have had babies born with disabilities claim they were not sufficiently warned about them.
- Epilepsy drug warnings during pregnancy ‘not reaching women’
- Nurses ‘must have time’ to discuss valproate risks
The new regulatory measures announced today also include a ban on the use of valproate for migraine or bipolar disorder during pregnancy. In addition, they ban the use of valproate to treat epilepsy during pregnancy unless there is no other effective treatment available.
Meanwhile, a visual warning of the risks must also be placed on packaging and warnings included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
“This is a landmark moment for all women who have ever been prescribed sodium valproate”
The restrictions were agreed by the European medicines regulatory body the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which has published a position statement titled Valproate and related substances.
The CMDh decision was reached by a majority vote, so it will now be sent to the European Commission, which will take a final, legally binding decision across Europe.
The epilepsy drug, prescribed to around 28,000 women in the UK each year, can cause physical disabilities and developmental problems for some babies exposed to it during pregnancy.
Up to four in 10 babies are at risk of developmental disorders, and around one in 10 are at risk of birth defects, according to the Medicines and Healthcare products Regulatory Agency. Sodium valproate is sold in the UK under brand names such as Epilim, Epival, Episenta, Convulex and Orlept.
The new measures follow an extensive 12-month review of valproate by the European Medicines Agency, which was started in March last year at the request of French medicines regulators.
The review was based on feedback from women with epilepsy, carers, healthcare professionals and other experts through a public hearing, stakeholder meeting and scientific advisory group.
“We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy”
The CMDh agreed with the EMA review that, despite previous recommendations aimed at better informing patients of the risks of valproate, women were “still not always receiving the right information in a timely manner”.
As a result, the body said that valproate medicines should now be contraindicated in females of childbearing age “unless the terms of a special pregnancy prevention programme are followed”.
The main points of the programme include performing an assessment of each patient’s potential for becoming pregnant and pregnancy testing before starting and during treatment, as needed.
Counselling should also be given about the risks of valproate and the need for effective contraception throughout treatment, with a review of ongoing treatment by a specialist at least annually.
In addition, it noted the introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood. Nursing Times understands that a standard version of the form will be introduced for the UK.
Dr June Raine, director of MHRA’s vigilance and risk management of medicines division, said: “We welcome the CMDh endorsement of the strengthened regulatory position on valproate medicines which we have been championing through the Europe-wide review.
“Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy,” she said in a statement today.
“This regulatory position has been developed through close collaboration with professional bodies, health system organisations, and patient and campaign groups,” she added.
Clare Pelham, chief executive of Epilepsy Society, said: “This is a landmark moment for all women who have ever been prescribed sodium valproate for their epilepsy.
“It is quite literally unbelievable how long it has taken to bring about this straightforward change to ensure all women and girls of childbearing age will have an annual conversation with their doctor to warn them of the risks of taking sodium valproate when pregnant,” she said.
She added: “It has been a long time coming, but the new guidelines are the result of great collaborative working between patient groups, charities, healthcare professionals and all those involved in the healthcare system.
“We are not complacent, however,” she said. “We will be diligent in carefully monitoring the impact of the new measures to ensure that they are robust and effective.”
Earlier this year, health and social care secretary Jeremy Hunt announced a review into the way concerns over side effects from three treatments, including sodium valproate, had been handled by the NHS.