Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
AUDIENCE: Patient, Health Professional, Oncology
ISSUE: The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. We are reviewing additional data and will communicate our conclusions and recommendations when our review is complete.
BACKGROUND: The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at risk for bronchiolitis obliterans syndrome. The manufacturer of brand name azithromycin is providing a Dear Healthcare Provider letter on this safety issue to health care professionals who care for patients undergoing donor stem cell transplants.
Azithromycin is not approved for preventing bronchiolitis obliterans syndrome. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body. The drug has been used for more than 26 years. It is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. It works by stopping the growth of bacteria that can cause infections.
RECOMMENDATION: Health care professionals should not prescribe long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome to patients who undergo donor stem cell transplants because of the increased potential for cancer relapse and death.
Patients who have had a stem cell transplant should not stop taking azithromycin without first consulting with your health care professional. Doing so could be harmful without your health care professional's direct supervision. Talk with them if you have any questions or concerns about taking this medicine.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/Drugs/DrugSafety/ucm614085.htm
Azithromycin為美國FDA核可之抗生素，用以治療肺、鼻竇、皮膚和身體其他部位的多種感染，作用機轉為阻止可能導致感染的細菌生長。該藥品已於美國上市使用超過26年。它以Zithromax和Zmax之商品名銷售，並由許多不同的製藥公司作為學名藥銷售。
閉鎖性細支氣管炎(bronchiolitis obliterans syndrome)是一種嚴重的肺部疾病，主要為肺部的氣管發炎和結痂而導致嚴重呼吸急促和乾咳的症候群，而長期使用azithromycin。接受異體幹細胞移植的癌症病人為出現閉鎖性細支氣管炎之高危險群。然而一臨床試驗結果發現，對於接受異體幹細胞移植(donor stem cell transplant)的血液或淋巴相關癌症病人，不應長期給予抗生素azithromycin以預防此種發炎性肺病，因會增加這類病人之癌症復發率（包括死亡）。
Azithromycin未被美國核准用於預防閉鎖性細支氣管炎。Azithromycin的製造商已提供醫療專業人員關於azithromycin之相關警訊 (Dear Healthcare Provider letter)。美國FDA也正在檢視其他資料，並會在文獻回顧完成後提供結論和建議供醫療專業人員參考。
建議：由於可能導致接受異體幹細胞移植的病人其癌症復發率和死亡的可能性增加，醫療專業人員不應該對此類病人長期開立azithromycin以預防閉鎖性細支氣管炎。進行幹細胞移植的病人不應在未事先諮詢專業醫療人員的情況下停止服用azithromycin，因為若無醫療專業人員的監測下直接停藥可能有害。如果病人對於服用該藥有任何問題或疑慮，請與醫療專業人員聯繫。
相關訊息與其他完整的建議請參考FDA網址：https://www.fda.gov/Drugs/DrugSafety/ucm614085.htm
[Posted 08/03/2018]
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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