Adverse Events Monitoring Data And Medical Studies Have Identified Possible Increased Risk For Cardiovascular Problems Including Arrhythmias

(Posted by Tom Lamb at DrugInjuryWatch.com)

In early May 2014 the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) announced it was reviewing the safety of hydroxyzine-containing medicines because of cardiac concerns.

Hydroxyzine is a medicine used generally by mouth or sometimes by injection for:

• relief of anxiety disorders;
• premedication before surgical procedures;
• relief of urticaria or various other conditions associated with pruritus (itching); and,
• treatment of sleep disorders.

In the US,  hydroxyzine-containing drugs include Atarax (Roerig, a division of Pfizer) and  Vistaril (Pfizer Labs and Roerig, each a division of Pfizer).

From this May 8, 2014 EMA Announcement, "Review of hydroxyzine-containing medicines started":

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)….

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.

We will watch for the results of this drug safety review in Europe concerning Atarax, Vistaril, and other hydroxyzine medications.

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