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Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms
AUDIENCE: Family Practice, Patient, Pharmacy, Health Professional
ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. FDA has issued a Drug Safety Communication today as a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
BACKGROUND: Azithromycin is marketed under the brand names Zithromax and Zmax. Change to “FDA-approved indications for azithromycin include: acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, genital ulcer disease
RECOMMENDATION: Health care professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events. FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.
Read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA提醒大眾azithromycin可能引起心臟異常的電生理變化，導致潛在性致命的不規則心跳節律。可能產生此風險之 病人如：已發生過QT間期延長、低血鉀或低血鎂、心跳速率較慢者，或正使用某些治療心臟節律異常或心律不整之藥物。FDA根據醫療研究人員與藥廠對此藥之 研究發布藥物安全警訊，評估azithromycin引起心電異常變化之潛在危險性。
FDA先前於2012年5月17日發布聲明，比較使用抗生素azithromycin、amoxicillin、ciprofloxacin及 levofloxacin，與無使用抗生素治療之病人，其發生因心血管疾病死亡的風險。該報告指出以azithromycin治療五天，相較於 amoxicillin、ciprofloxacin或無使用抗生素治療者，其發生因心血管疾病死亡之風險較高。使用levofloxacin治療產生之 風險與azithromycin類似。
Azithromycin之FDA核准適應症更改為：慢性阻塞性肺病急性細菌惡化、急性細菌性鼻竇炎、社區型肺炎、咽喉炎/扁桃腺炎、非複雜性皮膚感染、尿道炎、子宮頸炎及生殖器潰瘍。
醫療專業人員應注意具有心血管疾病風險之病人使用azithromycin可能會有尖端扭轉型心室性心搏過速與致命性心臟節律的風險。FDA指出，在選擇 抗生素時，應注意azithromycin可能會引起QT間期延長的風險，在選擇替代藥物時也須考量巨環類或非巨環類抗生素如 fluoroquinolones，也有QT間期延長或其他顯著副作用。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm343350.htm
[Posted 03/13/2013]
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
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資料來源：藥師週刊（第1815期）