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Medication safety

European Medicines Agency announces first public hearing to gather evidence for valproate safety review

Members of the public are being invited to speak about their experiences of an epilepsy drug as part of a safety review by the European Medicines Agency (EMA).

The drug safety agency announced on 10 March 2017 that it is to hold its first public hearing as part of its review into valproate-containing medicines.

Details of when the public hearing will take place and how to take part are due to be revealed in June by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), which decided at its March meeting that a public hearing should be held as part of the review.

The PRAC review was launched at the request of the French medicines regulator — the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)  — which has questioned the effectiveness of existing warnings and prescribing restrictions attached to valproate products. The warnings highlight the potential risks of malformations and developmental problems in babies born to women who take the drug during pregnancy.

Valproate-containing medicines are available across the EU for the treatment of epilepsy and bipolar disorder. In some European countries they are also available to treat migraine.

In a statement, the EMA says: “The PRAC has decided to organise a public hearing as part of the review of valproate to listen directly to the experience of EU citizens with these medicines, so this can be taken into account in the committee’s recommendation.”

In the UK, the risks associated with valproate were specifically highlighted by the Medicines and Healthcare products Regulatory Agency in January 2015 when it reiterated EMA advice that if valproate is the only treatment option, women of childbearing age should be given effective contraception. Women taking valproate must also have regular reviews of their treatment, it said at the time.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202448

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