The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has said that the drug hydroxyzine is associated with a “small but definite risk” of abnormal heart rhythms and cardiac arrest. This was the conclusion of the Committee’s review of the drug which began in April 2014 in response to a notification by Hungary, the lead member state for signals of this active ingredient.

Hydroxyzine is available in most EU countries with a variety of indications. It is used as an antihistamine, antipsychotic, anxiolytic and sedative and is marketed under several names, including Vistaril (hydroxyzine pamoate; Pfizer) and Atarax (hydroxyzine hydrochloride; Alliance Pharmaceuticals).

The Committee recommends that hydroxyzine-containing medicines can still be used provided that steps are taken to minimise the risk it poses of heart rhythm disorders. These measures include taking the drug at the lowest effective dose and for as short a period as possible.