Other safety alerts
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| Canada: ATARAX (hydroxyzine) - Risk of QT Prolongation and Torsade de Pointes |
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A Health Canada safety review has demonstrated that ATARAX (hydroxyzine) has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT prolongation (QTP) and cardiac arrhythmia events including torsade de pointes (TdP).
ATARAX (hydroxyzine) is an H1-antihistamine agent, and is indicated for use in the management of anxiety; for premedication, such as preparation for dental procedures; for the management of pruritus due to allergic conditions; and in the control of nausea and vomiting (except in pregnancy). Atarax can increase the risk of QTP and TdP which may lead to dizziness, palpitations, syncope, seizures, and sudden cardiac death.
ATARAX is now contraindicated in patients with a history of QTP and/or TdP; history of cardiac arrhythmias; significant electrolyte imbalance; significant bradycardia; family history of sudden cardiac death and concomitant use of other QT/QTc-prolonging drugs or of CYP3A4/5 inhibitors.
ATARAX should be used for as short a duration as possible and at the lowest effective dose up to specified maximums. The revised daily maximum oral dose is a total of 100 mg in adults, 50 mg in the elderly (if use cannot be avoided) and 2 mg/kg/day in children and adolescent up to 40 kg, in divided doses.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../58758a-eng.php
In Hong Kong, there are 15 registered pharmaceutical products containing hydroxyzine, and are prescription only medicines. Related news on the risk of QTP and TdP was previously issued by the EMA, MHRA and Singapore HSA, and was posted on the Drug Office website on 9 May 2014, 14 February, 28 March, 30 April and 18 August 2015. Letters to local healthcare professionals to draw their attention to the risk were issued on 16 February 2015. So far, the Department of Health (DH) has not received any adverse drug reaction case related to hydroxyzine. GlaxoSmithKline Limited (GSK) is the registration certificate holder of three branded pharmaceutical products containing hydroxyzine, namely Atarax Film-coated Tab 10mg (HK-24239), 25mg (HK-24218) and Atarax Syrup 10mg/5ml (HK-24243). GSK has already updated the package insert of Atarax Tab 10mg and 25mg to contain the relevant information. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Tuesday, June 07, 2016
Issued at HKT 15:00
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