Other safety alerts
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| Australia: Monitoring Communication: Ivabradine (Coralan) and cardiovascular events in patients with angina |
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The TGA is reviewing new information regarding ivabradine (Coralan) identified in the preliminary results of a study into the medicine. Ivabradine can be used to treat heart failure and stable angina. It is included on the Pharmaceutical Benefits Scheme (authority required) for patients with chronic heart failure who meet the clinical criteria set out in the schedule. Preliminary results from the SIGNIFY study have indicated that some patients with angina have a small but statistically significant increase in the combined risk of death and non-fatal heart attack compared to placebo. An early analysis of the SIGNIFY data indicates that cardiovascular adverse events may be associated with the patient's heart rate being less than 60 beats per minute. The incidence of bradycardia was high for ivabradine compared to placebo (17.9% vs 2.1%), with more than 30% of the patients in the ivabradine group having a resting heart rate below 50 beats per minute on at least one occasion. The findings of this study are currently being evaluated. The TGA is continuing to monitor all adverse event reports involving ivabradine. Consumers who have a slow heart rate (less than 60 beats per minute) or any related symptoms, such as dizziness, fatigue and low blood pressure, should seek medical attention.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/safety/ews-medicine-ivabradine-140623.htm#.U6eAskzyx9A
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. They are registered by Servier Hong Kong Ltd. Related news was released by the European health authority and was posted on the Drug Office website on 9 May 2014. 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 on the drug and actions taken by overseas regulatory authorities for consideration of any action deemed necessary.
Ends/ Monday, June 23, 2014
Issued at HKT 13:00
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