Other safety alerts
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| The United States: Multaq (dronedarone): Drug Safety Communication - increased risk of death or serious cardiovascular events |
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This update is in follow-up to the FDA Drug Safety Communication on July 21, 2011 about Multaq (dronedarone) and increased risk of death and serious cardiovascular events. The FDA completed a safety review of Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, PALLAS and ATHENA. FDA is providing new information and recommendations for the use of Multaq to manage the potential serious cardiovascular risks with the drug. The Multaq drug label has been revised with the following changes and recommendations:
- Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.
- Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
- Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF).
- Patients prescribed Multaq should receive appropriate antithrombotic therapy.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm
In Hong Kong, Multaq (dronedarone) is registered by Sanofi-Aventis HK Ltd., and is a prescription-only medicine. The risk of cardiovascular events has been released by the EMA, Health Canada and the US FDA and was posted on the website of Drug Office in July, August, September and December 2011. Letters to inform healthcare professionals were issued in July and September 2011. As reported on 23 September 2011, the matter will be discussed in the Registration Committee of Pharmacy and Poisons Board.
Ends/ Tuesday, December 20, 2011
Issued at HKT 12:30
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