EMA’s PRAC recommends new measures to minimize known heart risks of hydroxyzine-containing medicines

The European Medicines agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most European Union countries.

Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders. Hydroxyzine, a first-generation antihistamine, was first synthesized by Belgian drugmaker UCB (Euronext Brussels: UCB) in 1956, and has been sold under brands including Vistaril and Atarax.

The PRAC considered that hydroxyzine was associated with a small but definite risk of QT interval prolongation and torsade de pointes (alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest). Based on the assessed data, the risk did not differ between indications, and the Committee recommended that hydroxyzine could continue to be used provided that measures to minimize the risk of problems with heart rhythm were taken.