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FDA Safety Alert: Azithromycin

August 6, 2018

The Food and Drug Administration (FDA) has issued a safety alert, warning that 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.

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. 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 FDA reports that results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. The FDA is reviewing additional data and will communicate conclusions and recommendations when the review is complete.


Food and Drug Administration (FDA). Safety Alerts for Human Medical Products: Zithromax, Zmax (azithromycin): FDA Warning – Increased Risk of Cancer Relapse with Long-Term Use after Donor Stem Cell Transplant. August 3, 2018. Available at: click here. Accessed August 3, 2018.