EU Regulators to Hold Public Hearing on Valproate Therapies’ Effect on Pregnant Women

EU Regulators to Hold Public Hearing on Valproate Therapies’ Effect on Pregnant Women

The European Medicines Agency has scheduled an unprecedented public hearing in September on whether epilepsy therapies that contain sodium valproate pose a risk to pregnant women.

It will be the first time the European Union’s drug-regulating agency will make a hearing part of a therapy review process. The event is scheduled for Sept. 26 at its offices in London.

Hearings can give government agencies insight into people’s thoughts about sensitive topics. Here is a video on the process.

The European Medicines Agency’s safety committee scheduled the event to hear people’s experiences with sodium valproate therapies firsthand, said an agency spokesperson, Camelia Enachioiu.

“These contributions can be taken into account” when the committee recommends whether the European Union should approve the therapies, she said in a press release.

This kind of hearing will give “EU citizens a voice in the evaluation of the safety of medicines and empower them to express their views,” she added.

Although sodium valproate is an effective epilepsy treatment, it increases the risk that a pregnant woman  will have a child with a birth defect.

The agency not only wants to hear people’s thoughts on the risk of a pregnant woman taking valproate medicines but also on ways to reduce that risk.

To attend the hearing, people must fill out an application form available here and notify the agency of their interest at publichearings@ema.europa.eu by Aug. 25.

You can ask to speak at the event or simply observe the discussion.

The agency will provide those who attend with a summary of concerns about the safety of valproate medicines and a list of questions to be covered.

Because of space restrictions, the agency said it will likely be unable to accept all applications. It will  broadcast the event live on its website, however.

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