Epilepsy Care Group Singapore Awareness Association: Survey reveals new safety warnings on antiepileptics not received by pregnant women

Antiepileptic drugs and the potentially harmful effects on unborn children has hit the headlines as a survey reveals many women have not received the new safety warnings about the dangers of taking it during pregnancy.

In an exclusive story from the BBC, it has been revealed that out of the 475 women under 50 currently taking Epilim (sodium valproate) nearly 70% had not received the new warnings. These new warnings, known as the Valproate Toolkit, were launched in February 2016. Created by the European Medicines Agency (EMA) the aim of the toolkit was to improve patient information about the risks of neuro-developmental disorders in unborn children.

The data extracted from a survey of 2,000 women and girls, commissioned by three charities — Epilepsy Society, Epilepsy Action and Young Epilepsy — also demonstrated that one in six women taking the drug were not aware of the negative affects it may have on the development and/or physical health of an unborn child. In the UK alone about 20,000 children have been affected by antiepileptic medicines (valproate medicines) since the 70s.

A public hearing concerning sodium valproate will take place on 26 September at the EMA’s London offices in Canary Wharf. The survey results will be presented during this hearing, which is the first time the agency’s safety committee has held a public hearing as a part of a safety review of a medicine.

During this session, women will be able to recount their personal experiences of taking the medication to the agency’s safety committee. The hearing will be focus on three main areas: the risks of the medication in pregnancy, the current measures in place to reduce the risks of using valproate in pregnancy and the measures that should be taken to reduce the risks associated with the medication and its use in pregnancy.

The Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK explained that valproate was constantly reviewed and warnings surrounding the medication were updated as and when new data were made available. “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,” the agency said to the BBC. “We constantly monitor the safe use of valproate and support this latest review by the European Medicines Agency on the use in pregnancy and women of childbearing age.”

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