On September 26 the European Medicines Agency (EMA) was host to a historic event, a public hearing. This specific public hearing was part of a review of the safety of using Valproate containing medicines in women and girls who are pregnant or of childbearing age was held by EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The public hearing was broadcasted live on EMA’s website, very well received and paved the way for future reviews of this kind.
Patients, parents and representatives from different disease areas who fall into the category of those using Valproate gave convincing and emotional accounts of how children have been so badly affected by mothers using this medicine. Valproate is a very effective medicine for epilepsy, severe migraine, among many other conditions, however, measures were put into place to reduce its use to protect the unborn.
There is very little information and investigation leading to 70% of women using Valproate not being informed properly. The drug was first licenced in 1973 and it took 44 years for the warning to be made public. In France alone, 4900 children have been affected and legal action against the pharmaceutical has recently led to compensation to those affected.
Valproate is a lifesaving medicine for some women who are resistant to other drugs but the drug carries many health risks. Stopping this medication should only be considered after a careful benefit/risk assessment.
Member of the European Parliament (MEP) Mrs Linda McAvan reported that MEPs and Ministers of Health in all European Union (EU) Member States agree to bring transparency and to involve more patients into the review system. Reporting issues on safety can be done by written contributions after this hearing and will be published.
By Jose Drabwel
IPOPI President and Member of the EMA Patients’ and Consumers’ Organisations Working Party