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Singapore: Atarax (hydroxyzine) – New restrictions for hydroxyzine-containing medicines to further minimise the known risk of QT prolongation
 
GlaxoSmithKline (GSK) Pte Ltd informed healthcare professionals that the European Medicines Agency (EMA) has recently strengthened warnings related to the safety of hydroxyzine-containing products to minimise the risk of QT prolongation. EMA’s review confirmed the previously known risk of QT prolongation and torsades de pointes and identified risk factors. As a result of this analysis and review, new restrictions have been introduced in the EU with the aim of reducing exposure to the medicine, particularly in the most vulnerable groups. Hydroxyzine should also be used at the lowest effective dose, for the shortest possible treatment duration.

GSK will be updating the package insert for Atarax products in Singapore to strengthen the warnings and impose further restrictions on the use of hydroxyzine.

Please refer to the following website in HSA for details: http://www.hsa.gov.sg/content/hsa/../Dear_Healthcare_Professional_Letters.html

In Hong Kong, there are 15 registered pharmaceutical products containing hydroxyzine, and are prescription-only medicines. Related news has been issued by the EMA and MHRA, and was posted on the Drug Office website on 9 May 2014, 14 February, 28 March and 30 April 2015. Letters to local healthcare professionals to draw their attention to the warning were issued on 16 February 2015. So far, the Department of Health (DH) has not received any adverse drug reaction case on hydroxyzine. GlaxoSmithKline Limited (GSK) is the registration certificate holder of three branded pharmaceutical products containing hydroxyzine, namely Atarax Film-coated Tab 25mg (HK-24218), Atarax Film-coated Tab 10mg (HK-24239) and Atarax Syrup 10mg/5ml (HK-24243). GSK notified DH that the company had issued a "Dear Healthcare Professional Letter" to inform the local healthcare professionals about the new restrictions on 16 July 2015. As previously reported, DH will maintain close contact with GSK to monitor any action deemed necessary, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.

Ends/ Tuesday, August 18, 2015
Issued at HKT 13:00
 
Related Information:
Canada: ATARAX (hydroxyzine) - Risk of QT Prolongation and Torsade de Pointes Posted 2016-06-07
The United Kingdom: Drug safety update: Hydroxyzine (Atarax, Ucerax): risk of QT... Posted 2015-04-30
European Union: New restrictions to minimise the risks of effects on heart rhyth... Posted 2015-03-28
New Measures to Minimise Known Heart Risks of Hydroxyzine-containing Medicines (... Posted 2015-02-16
European Union: PRAC recommends new measures to minimise known heart risks of hy... Posted 2015-02-14
European Union: Review of hydroxyzine-containing medicines started Posted 2014-05-09
 
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