PRAC News – February 2015


At its February 2015 meeting, the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) adopted recommendations regarding heart risks associated with use of hydroxyzine-containing medicines.

PRAC recommends new restrictions to minimise known heart risks of hydroxyzine-containing medicines

The PRAC has completed a review of safe use of hydroxyzine-containing medicines, initiated due to concerns over the risk of possible effects on heart rhythm with these medicines. The PRAC considered that hydroxyzine was associated with a small but definite risk of QT interval prolongation and torsade de pointes. The prolongation of QT interval is a condition with alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest. Torsade de pontes is a serious life-threatening abnormality of the heart rhythm preventing an adequate expulsion of blood from the heart and therefore this condition requires an urgent medical intervention.

With the aim to minimise these risks, the PRAC recommends a number of measures including implementation of this information into the summary of product characteristics and package leaflet.

Hydroxyzine-containing medicines are authorised for various indications including the relief of pruritus (itching) and treatment of anxiety disorders, as premedication before surgery, and for treatment of sleep disorders and are placed on the market in most of the EU countries. There are no authorised medicines in Croatia with this active substance.

The PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedure (CMDh), who will take the final decision.

More information on the PRAC meeting from February 2015 is accessible here.