The TGA has completed its safety review of ivabradine (Coralan).
A safety advisory regarding the increased risk of heart problems in patients with angina, which is based on the findings of this review, has been published on the TGA website.
Further information for health professionals is available in a related article that was published in the June 2015 issue of the TGA's Medicines Safety Update.
Monitoring communication
23 June 2014
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.
The SIGNIFY study is evaluating the efficacy of ivabradine in patients who have a type of heart disease affecting the blood vessels that supply the heart, but no heart failure. The findings of this study are currently being evaluated.
Preliminary results from the 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 TGA is continuing to monitor all adverse event reports involving ivabradine. Please report all suspected adverse events.
Information for consumers
This monitoring communication highlights a potential safety concern. Patients should continue taking their medicine until advised otherwise by their health professional.
However, if you are taking ivabradine and have angina, check with your health professional to make sure that this medicine is still appropriate for you.
If you experience a slow heart rate (less than 60 beats per minute) or any related symptoms, such as dizziness, fatigue and low blood pressure, seek medical attention.
If you have any questions or concerns about this issue, speak to your health professional.
Information for health professionals
The sponsor, Servier Australia, has written to health professionals to provide further information about this issue.
You are reminded of the approved indications for ivabradine (treatment of chronic heart failure and treatment of coronary artery disease) and are advised to take note of the relevant precautions in the Product Information, particularly in relation to heart rate.
You should discuss the benefits and risks of ivabradine treatment with patients who are taking, or for whom you may prescribe, this medicine.
If you have any questions or concerns regarding this issue, contact Servier Australia on 1800 153 590.
Reporting problems
In addition to adverse events involving ivabradine, consumers and health professionals are encouraged to report all problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.