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Zithromax (azithromycin): FDA Statement on risk of cardiovascular death
Read the MedWatch safety alert, including a link to the Drug Safety Communication at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
Audience: Primary Care, Pharmacy
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small 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. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
BACKGROUND: Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.
RECOMMENDATION: Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
FDA提醒醫療人員，2012年5月17日the New England Journal of Medicine發表一篇研究，內容為使用azithromycin治療5天的病人，相較於用amoxicillin、ciprofloxacin或不以 藥物治療的病人，因心血管或其他原因導致死亡的機率有些微增加。FDA正在評估此研究的結果，當評估完後，將會發布相關的完整資訊。
Azithromycin屬於macrolide類的抗生素，這類藥物有相關的心血管副作用，特別是QT interval prolongation。2011年時，FDA重新審視macrolide類抗生素的仿單中關於QT interval prolongation與TdP的部份。2012年3月時，Zmax (azithromycin extended release for oral suspension)仿單更新WARNING AND PRECAUTION，說明此藥引起QT interval prolongation的風險為低風險。而clarithromycin與erythromycin仿單中WARNING部分也提及關於QT interval prolongation的風險。FDA正在將此風險資訊更新至其他macrolide類藥物的仿單。
建議正在服用azithromycin的病人，在未與醫療人員討論前勿擅自停藥；而醫療人員在處方macrolide類藥物時，應對病人可能產生QT interval prolongation及心律不整有所警覺。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm304503.htm
[Posted 05/18/2011]
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
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資料來源：藥師週刊（第1777期）