藥物警訊（藥師週刊第1759期）

Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events

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.

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

FDA已完成基於PALLAS與ATHENA臨床試驗的Multaq （dronedarone）安全性評估，顯示當Multaq用於治療永久性心房纖維顫動（permanent atrial fibrillation, AF）時，會增加包括死亡在內的嚴重心血管事件風險；因此FDA提供關於使用Multaq的新資訊與建議。

Multaq藥品仿單已被更新如下：

● 醫療人員不可處方Multaq給患有permanent AF的病人，因為會加倍此種病人罹患心血管死亡（cardiovascular death）、中風（stroke）及心衰竭（heart failure）的風險。

● 醫療人員應至少每3個月以心電圖(electrocardiogram, ECG)監測病人心律，如果病人正處於AF的狀態，應停止使用Multaq，或者依臨床需求將病人心臟去顫（cardioverted）。

● Multaq可降低有陣發性（paroxysmal）或持續性（persistent）AF病史病人的住院風險。

● 服用Multaq的病人需接受適當的抗血栓治療。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm264204.htm
[Posted 12/19/2011]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部