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The agency is asking the public to share their experiences with the drug so EMA can determine its safety.
On July 11, 2017, the European Medicines Agency announced it was holding a public hearing on Sept. 26, 2017 so that the public can share their experiences with valproate-containing drugs. The hearing is being held as part of the agency’s Pharmacovigilance Risk Assessment Committee’s (PRAC) evaluation of the safety of using valproate-containing medicines in pregnant women or women of childbearing age.
The PRAC review of valproate is a result of concerns that current measures in the European Union regarding valproate are not effective enough. According to EMA, babies exposed to valproate in the womb are at risk of malformations and neurodevelopmental problems.
“Patients are experts in their condition and we need to listen directly to what they have to say so their experience can be reflected in our scientific evaluation. This adds to our already existing initiatives to include patients in our work, such as our Patients' and Consumers' Working Party,” EMA’s Executive Director, Guido Rasi, said in a press release.
EMA is asking those interested in participating in the hearing to submit an application by Aug. 25, 2017. PRAC has put together a list of three questions to be answered by the speakers, which can be found on the agency’s website.