PRAC Reviewing Safety of Hydroxyzine-Containing Drugs

Megan Brooks


May 09, 2014

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of hydroxyzine-containing medicines because of cardiac concerns.

Hydroxyzine-containing medicines are approved in most European Union (EU) countries for a variety of uses, including treatment of pruritus and anxiety disorders, as premedication before surgery, and for sleep disorders.

The review was requested by the Hungarian medicines agency because of concerns about the adverse effects of these medicines on the heart, the EMA said in a statement May 8.

Safety monitoring data for these medicines and published experimental studies have identified a potentially increased risk for alterations of the electrical activity of the heart and arrhythmias, the EMA said. "As hydroxyzine-containing medicines are approved in other EU countries, the Hungarian agency decided to trigger an EU-wide review," the EMA said.

The PRAC will review the available data on the benefits and risks of hydroxyzine-containing medicines in all authorized indications and issue an opinion on the marketing authorizations of these medicines across the EU.

The PRAC recommendation will be forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures–Human, which will adopt a final position.

While the review is ongoing, patients with questions or concerns are being advised to speak to their physician or pharmacist.


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