ADR that result in revision of patient information
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| European Union: New restrictions to minimise the risks of effects on heart rhythm with hydroxyzine-containing medicines |
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The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has agreed by consensus new measures to minimise the risk of effects on heart rhythm with medicines containing the antihistamine hydroxyzine. The measures include restricting use of hydroxyzine in patients at high risk of heart rhythm problems and using the medicine at the lowest effective dose for as short a time as possible.
Hydroxyzine medicines are available in most European Union countries. Their approved uses (indications) vary between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and treatment of sleep disorders.
Recommendations for these new measures were originally made by European Medicines Agency (EMA) 's Pharmacovigilance Risk Assessment Committee (PRAC), which confirmed a previously known risk of QT interval prolongation and torsades de pointes, alterations in the electrical activity of the heart that can lead to abnormal heart rhythms and cardiac arrest (stopping of the heart). Having assessed the available evidence, including published studies and data from regular safety monitoring, the PRAC concluded that the risk did not differ between indications and that such events are most likely to occur in patients who have risk factors. The PRAC therefore recommended that the risk be managed by restricting hydroxyzine use in those most at risk of heart rhythm problems and reducing exposure to the medicine.
As the CMDh has now agreed the PRAC measures by consensus, the measures will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable. In particular, the product information of hydroxyzine-containing medicines will be updated with new dosing recommendations and warnings on use in patients who have risk factors for heart rhythm disturbances or who are taking certain other medicines
Please refer to the following website in EMA for details:http://www.ema.europa.eu/../news_detail_002296.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 16 registered pharmaceutical products containing hydroxyzine and they are all prescription-only medicines. Related news had been reported by EMA and was posted on the Drug Office website on 9 May 2014 and 14 February 2015. A letter to healthcare professionals was issued on 16 February 2015 to draw their attention on the matter. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to the drug. In view of the new EMA's announcement, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on any safety updates of the drugs and regulatory actions taken by other overseas health authorities.
Ends/ Saturday, March 28, 2015
Issued at HKT 13:30
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 the DH that the company is going to issue a "Dear Healthcare Professional Letter" today to inform the local healthcare professionals about the new restrictions for hydroxyzine-containing medicines to further minimise the known risk of QT prolongation. The DH will maintain close contact with GSK to monitor any action deemed necessary. As previously reported, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Content last updated: Thursday, July 16, 2015
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