The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) assesses risk management of medicines used in humans. The committee has said new measures should be put in place to avoid babies being exposed to this medicine in the womb. This follows the recent safety review by the EMA into sodium valproate and the public hearing held last year.
Sodium valproate is an epilepsy medicine which can be very effective in treating seizures in some people. For some people, it may be the only medicine that works.
However, recent reports have highlighted the risks of taking sodium valproate during pregnancy. Babies born to women taking this medicine are at an increased risk of having birth defects and developmental problems.
The new recommendations say that for women with epilepsy, sodium valproate should not be used during pregnancy. However, the recommendations acknowledge that in some women with epilepsy, it may not be possible to stop using the medicine. This is because it may lead to breakthrough or worsened seizures, which can be harmful to the woman and baby. In this situation, the recommendations say women should have appropriate specialist care.
In women of a childbearing age, the recommendations say that sodium valproate should not be used unless measures are taken to help the woman avoid becoming pregnant. The PRAC suggests that a pregnancy prevention programme should be created for this.
The pregnancy prevention programme would assess the potential of a woman becoming pregnant, depending on her circumstances. It would suggest pregnancy tests are taken during the treatment as needed. The committee says counselling should be provided about the risks to pregnancy as part of the programme. It also suggests that there should be annual reviews of the treatment. PRAC recommends that a risk acknowledgement form should be introduced, for people to go through with their doctors at each review.
Alongside these recommendations, the committee has also said that there should be a visual warning on the medicines’ packaging. They recommend a symbol or a pictogram. A reminder card should also be attached to the packaging to help pharmacists discuss the risks of valproate. The committee is also calling on companies marketing the medicine to provide updated educational materials.
Recommendations reflecting seriousness of risks
Dr Jim Morrow, founder of the UK Epilepsy and Pregnancy Register and member of Epilepsy Action’s Women’s Advisory Panel, said:
“We are pleased the European Medicines Agency committee has listened to people’s concerns about sodium valproate and that their recommendations reflect the seriousness of the risks involved for women with epilepsy in pregnancy. We know sodium valproate is an effective, easy-to-use and generally well-tolerated drug for women with epilepsy. Unfortunately, this means non-neurology specialists are more likely to prescribe it, which can mean women can take the drug without being fully aware of the risks involved or having regular reviews.
“For many women with epilepsy, sodium valproate is the only drug that works. However, we know for most others, there are equally effective and well-tolerated epilepsy medicines which are safe to use in pregnancy. We would have liked to see the guidelines state that valproate should not be prescribed as a first-line treatment without a full discussion with a specialist.
“It remains to be seen how and when these recommendations will be implemented and we would like the opportunity to meet UK decision makers to see how they will work in practice. Until things change, women and children will continue to be affected by something that can be potentially prevented.”
Sodium valproate can be used to treat other conditions as well as epilepsy, including bipolar disorder and migraines. For epilepsy, it is often prescribed under the names Epilim, Epival, Episenta, Convulex and Orlept.
This medicine has recently been discussed in Parliament. MPs have called for a public inquiry to find out why the risks of this medicine have not been more widely publicised until now.
There is more information about sodium valproate on the Epilepsy Action website.
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A parliamentary debate was held in the House of Commons in London on 19 October. At the debate, MPs discussed sodium valproate and foetal anticonvulsant syndrome.