Women with epilepsy who are pregnant or are planning to start a family may be worried about their treatment options, as a study has brought attention to the fact one type of epilepsy drug could harm their unborn children.
According to the charities, 10% of babies born to women who take sodium valproate during pregnancy are born with physical disabilities, and up to 40% are at risk of developmental issues that can lead to learning difficulties.
Michelle Hackett, who started taking sodium valproate after the birth of her first child when she was 16, said she was “furious” that she wasn’t told about the side effects of the drug.
Her second baby was born a year later with six toes on each of his feet, an underlying jaw and, when his teeth came through, eight of them were black and rotten.
“I asked why I hadn’t been told about the dangers around Epilim [sodium valproate] but they said because I was young, they didn’t think I would get pregnant again,” she said.
“I feel absolutely furious that I wasn’t told about the side effects of Epilim. When I hear about mums with Epilim and what they go through it is heartbreaking.”
The survey also found that just over a quarter (28%) of women currently taking sodium valproate had not been given information about risks for children during pregnancy.
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.
“Discussions with a health professional about these risks should be a mandatory part of care for all women with epilepsy.”
The results of the survey are in spite of efforts by the Medicines and Healthcare products Regulatory Agency (MHRA) to raise awareness of the issue among healthcare professionals and women with epilepsy.
In February 2016, the MHRA released a “valproate toolkit” to help healthcare professionals talk to women with epilepsy about the risks during pregnancy.
The toolkit includes a credit card-sized patient card to be issued by pharmacists, booklets for healthcare professionals and women taking sodium valproate, and a checklist of important discussion points.
However, 18 months later, the survey showed that more than two thirds (68%) of respondents currently taking sodium valproate have still not received any of the toolkit materials.
Carol Long, chief executive of Young Epilepsy, said: “It is important that women who may be planning to have a family receive the right advice at the right time; to prevent their unborn babies being put at risk.
“Sodium valproate can provide life-changing support for many young people with epilepsy. It is the third most-prescribed anti-epilepsy medication, however, the percentage of women who do not know the risks of taking the drug during pregnancy is far too high.
“Women must feel more empowered to discuss the issue with their epilepsy specialist, so that they can make a more informed decision about their future.”
So, what do women with epilepsy who are preparing to start a family need to know?
It’s hard to concretely say what medication is and isn’t safe during pregnancy, as it very much depends on the type of epilepsy a woman has and how she responds to certain medications. So it is vital to speak to your doctor about your options.
Speaking to HuffPost UK, Lee from Epilepsy Action said: “The risk of epilepsy medicines causing an unborn baby to have a major congenital abnormality seems to be greatest during the first three months of pregnancy.
“Current research suggests that carbamazepine, levetiracetam and lamotrigine are the epilepsy medicines which carry the lowest risk of a baby being born with major birth defects.
“If a woman with epilepsy takes sodium valproate rather than a different epilepsy medicine, the risk of her baby being born with abnormalities or developmental problems increases from two-three in a 100 to six-10 in a 100, depending on the dosage she takes.
“However, sodium valproate may be the only epilepsy medicine that controls her seizures.”
Lee said it is important that women planning to get pregnant or who find themselves pregnant seek medical advice and do not stop taking their medication, unless they have been advised to do so.
“Stopping taking epilepsy medicines could cause a mother to have seizures, which can put their lives and those of their babies at risk,” he added.
“With better information, care and treatment before and during pregnancy, it is possible to minimise the risks for more women with epilepsy.
“All epilepsy medicines bring side effects and potential risks in general.
“In pregnancy the risks of potential harm to the unborn baby need to be carefully balanced against the risk to the mother of not taking the medication (for example, breakthrough seizures or an increase in seizures, which in the worst case scenario can cause injury and even, death.”
In response to the findings of their survey, Epilepsy Action, Epilepsy Society and Young Epilepsy are now calling on the government to ensure that repeat prescriptions for sodium valproate for women and girls of childbearing age are not routinely renewed for more than 12 months without a face-to-face consultation with a doctor or nurse.
This consultation must include personal and tailored written information about the risks around sodium valproate during pregnancy.
Clare Pelham, chief executive at Epilepsy Society said: “This is a very simple and straightforward ask of the government. No additional funding is required for the NHS.
“All we are asking is that doctors and nurses have a yearly conversation with women and girls who are taking sodium valproate, to make absolutely certain they are aware of the risks associated with the drug during pregnancy.
“We know that for some women, sodium valproate will be the only drug that controls their seizures and they must carefully weigh the benefits against the risks.
“But what is unforgivable is for women not to be informed of those risks. They must be able to make an informed choice about their treatment in conjunction with their doctor.”
The survey is published in advance of the European Medicines Agency’s (EMA) public hearing into sodium valproate on 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 drug.
The three charities will be presenting the survey results at the hearing along with patient groups, healthcare professionals and other interested bodies from across Europe.