Other safety alerts
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| European Union: Review of hydroxyzine-containing medicines started |
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The European Medicines Agency (EMA) 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 EMA 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.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002098.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 16 registered pharmaceutical products containing hydroxyzine. All are prescription-only medicines. So far, the Department of Health (DH) has not received any adverse drug reaction report in connection with the drug. The DH will keep vigilant against any new safety updates with respect to the drug.
Ends/ Friday, May 09, 2014
Issued at HKT 13:00
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