The European Medicines Agency has started a review of hydroxyzine-containing medicines, which have been approved in most EU countries for a variety of uses including anxiety disorders, as premedication before surgery, for relief of pruritus (itching), and for sleep disorders.
The review was requested by the Hungarian medicines agency (GYEMSZI-OGYI) over concerns about the side effects of these medicines on the heart. This followed an examination of the benefits and risks by a marketing authorisation holder for hydroxyzine. Data from drug safety monitoring (pharmacovigilance) and published experimental studies identified a potentially increased risk of alterations of the electrical activity of the heart and arrhythmias (irregular heartbeats). As hydroxyzine-containing medicines are approved in other EU countries, the Hungarian agency decided to trigger an EU-wide review.
The European Medicines Agency will now review the available data on the benefits and risks of hydroxyzine-containing medicines in all authorised indications, and issue an opinion on the marketing authorisations of these medicines across the EU.
While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.