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Medication safety

Public invited to take part in EMA valproate safety review

The European Medicines Agency (EMA), the body that evaluates medicinal products for use in Europe, is holding its first public hearing to ask patients for their experience of taking valproate.

It is part of a review by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) on the safety of prescribing valproate-containing medicines to women and girls who are pregnant or of childbearing age.

Valproate is used to treat epilepsy, bipolar disorder and migraine.

According to the EMA, there is a risk of malformations and neurodevelopmental problems in babies who are exposed to valproate in the womb, and the review follows concerns that EU-wide risk minimisation measures currently in place do not seem to be sufficiently effective.

The BNF says valproate “should not be used in female children, in females of childbearing potential and pregnant females, unless alternative treatments are ineffective or not tolerated, because of its high teratogenic potential”.

The hearing — to be held on the 26 September 2017 in the EMA London offices — will help “enrich the available scientific evidence,” a statement said.

“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,” said Guido Rasi, executive director of the EMA.

“This adds to our already existing initiatives to include patients in our work, such as our Patients’ and Consumers’ Working Party,” he added.

Patients, affected families, doctors and researchers are all being encouraged to take part in the review.

Contributions will be taken into account in the committee’s safety review and will help the PRAC to “better understand public awareness of the risks and develop measures to reduce these risks,” the EMA said.

Anyone wanting to take part in the hearing, which will also be broadcast live, will need to apply by the 25 August 2017, and speakers will be selected based on their experience.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203178

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