The EMA is an agency which assesses and oversees the safety of medicines developed by pharmaceutical companies in the European Union (EU). The review is being done by one of the EMA’s committees which deals with the safety of medicines used to treat people. It is called the Pharmacovigilance Risk Assessment Committee (PRAC).
Sodium valproate is a very effective epilepsy medicine for some people. However, it has been linked to an increased risk of birth defects in babies born to women taking this medicine during pregnancy.
The EMA’s committee is aiming to find out if further measures are needed to reduce the risks of this medicine in pregnancy. Apart from treating epilepsy, medicines containing valproate are also used to treat other conditions, such as bipolar disorder.
In 2014, the EMA decided to strengthen warnings on valproate-based medicines about the risks it poses if taken during pregnancy. According to the agency, the new review was launched because of concerns that the warnings are still not effective enough.
Philip Lee, chief executive at Epilepsy Action, said: “We welcome this review. It is a significant step towards a fuller understanding of the potential impacts of taking sodium valproate for women of childbearing potential. It is vital that women with epilepsy get the right information about their care and treatment. Yet evidence suggests that conversations about the potential risks involved aren’t always happening. Women must be given the chance to make informed choices, ideally before they conceive.”
For the first time, as part of the review process, the committee will organise a public hearing in June. This is to allow people living in the EU who take these medicines, or work with them, to share their views and experiences.
A spokesperson for the EMA said: “Public hearings will give EU citizens a voice in the evaluation of the safety of medicines. The PRAC has decided to organise a public hearing as part of the review of [valproate] to listen directly to the experience of EU citizens. These contributions can be taken into account in the PRAC’s recommendation.”
People living in the EU, including people taking the medicine, doctors, industry members and academics, can take part in the public hearing, according to the EMA. People will be able to discuss their experience of the medicine when it comes to treating their condition but also when it comes to risks in pregnancy. They will be able to talk about other possible medicine options and give feedback on suggested ways to minimise the risk of this medicine.
The details of this public hearing have not yet been announced.
It is vital that women who are pregnant or of childbearing age taking sodium valproate continue taking their medicine as normal unless advised otherwise by their doctor. Women who are worried about their epilepsy medicines should seek advice from their doctor.