Other safety alerts
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| European Union: European Medicines Agency recommends measures to reduce risk of heart problems with Corlentor/Procoralan (ivabradine) |
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The European Medicines Agency (EMA) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine for angina. Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
When used for angina, Corlentor/Procoralan should only be started if the patient’s resting heart rate is at least 70 beats per minute (bpm). Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina. Doctors should consider stopping treatment if there is no improvement in angina symptoms after 3 months, or if the improvement is only limited.
Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). If atrial fibrillation develops during treatment, the balance of benefits and risks of continued Corlentor/Procoralan treatment should be carefully reconsidered.
The review of Corlentor/Procoralan was first carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC recommendations have now been endorsed by the Agency’s Committee for Medicinal Products for Human Use (CHMP) in its final opinion. The CHMP opinion will be sent to the European Commission, which will issue a legally binding decision valid throughout the EU in due course.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/../news_detail_002217.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are two registered pharmaceutical products containing ivabradine, namely Coralan Tab 7.5mg (HK-55438) and Coralan Tab 5mg (HK-55439) and both are prescription-only medicines registered by Servier Hong Kong Ltd. Related news was released by the Therapeutic Goods Administration and EMA, and was posted on the Drug Office website on 23 June 2014, 9 May 2014 and 8 November 2014 respectively. The Department of Health will remain vigilant on the final decision made by the European Commission and follow up any update on the relevant safety information.
Ends/Saturday, 22 November, 2014
Issued at HKT 13:00
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