More than a quarter (28%) of the women currently taking sodium valproate said in the survey that they had not been informed of the risks of this medicine in pregnancy.
The survey of over 2,000 women with epilepsy, aged 16-50, was carried out by charities Epilepsy Action, Epilepsy Society and Young Epilepsy between August and September 2017. It aimed to look into the awareness among women taking sodium valproate of the risks this medicine can pose during pregnancy.
Sodium valproate is prescribed in the UK under the brand names Epilim, Epilim Chrono, Epilim Chronosphere, Episenta and Epival. For some people with epilepsy, it is a very effective medicine to control seizures, and, in some cases, may be the only medicine that works.
However, sodium valproate is also linked to an increased risk of birth defects and developmental problems in babies born to mothers taking this medicine. The risk of physical disabilities in babies born to women taking sodium valproate is estimated to be around 1 in 10 (10%). The risk of developmental problems, which can lead to learning difficulties, is around 2 in 5 (40%).
Epilepsy Action advises that women do not stop taking their epilepsy medicines or change their dose without speaking to their doctor, as this could lead to breakthrough seizures.
Improving safety information
The charities carried out a similar survey in 2016. The results from this were very similar to the results of the 2017 survey. Of the women taking sodium valproate 1 in 5 (20%) said they didn’t know the risks of taking this medicine during pregnancy. Over a quarter (27%) of women taking sodium valproate said they had not had a discussion with their healthcare professional about the risks in pregnancy.
This lack of change has come despite efforts by the Medicines and Healthcare products Regulatory Agency (MHRA) to improve the situation. In February 2016, the MHRA released a valproate toolkit to help healthcare professionals talk to women with epilepsy about the risks of taking this medicine during pregnancy.
However, according to the 2017 survey, more than two-thirds of women (68%) taking sodium valproate said they have not received any materials from the MHRA toolkit.
A spokesperson from the MHRA explained that the agency had worked with the charities on the latest survey. The MHRA said: “The results of the survey are important in helping us understand the effectiveness of the measures taken to date in the UK. We want to encourage all women to have access to the valproate toolkit materials that we made available in February 2016.
“We constantly monitor the safe use of valproate and support this latest review by the European Medicines Agency (EMA) on the use in pregnancy and women of childbearing age.”
The results of the survey will be presented at the EMA’s public hearing on sodium valproate on Tuesday 26 September. The hearing, in London, will be the first time the EMA has held a public hearing as part of the safety review of a medicine.
Ensuring conversations happen
The charities are calling on the government to change the way repeat prescriptions of sodium valproate are made for women and girls of childbearing age. They are asking that repeat prescriptions are not routinely renewed for more than 12 months without a face-to-face consultation with a doctor or nurse. They say this consultation must include personal and tailored information about the risks around sodium valproate during pregnancy, and should also be provided in written format.
Philip Lee, chief executive at Epilepsy Action, said: “It is vital that women with epilepsy get the right information about their care and treatment to ensure a healthy pregnancy and minimise the risks associated with sodium valproate.
“Yet these figures suggest that information is not filtering down to women and that conversations about the potential risks are not always happening. Discussions with a health professional about these risks should be a mandatory part of care for all women with epilepsy so they can make informed choices, ideally before they conceive.”
Dr Rhys Thomas, honorary consultant in epilepsy at the Royal Victoria Infirmary in Newcastle, said: “This is a dramatic and important survey focusing on a crucial area for women with epilepsy. As a medical community, we clearly could be doing more, and should be doing more.
“Even if women are being told of the risks, this may be at the wrong time for them – or in the wrong way. The conversation needs to be had and repeated.
“Women who want to know more about their medication should ask to speak to their GP, epilepsy specialist nurse or neurologist. I would advise anyone who is taking medicines for their epilepsy not to change their tablets or dose without the support of their doctor.”
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The European Medicines Agency (EMA) is holding a public hearing on medicines containing valproate on 26 September 2017 at its London offices.