FDA warns of increased risk of cancer relapse with long-term use of azithromycin after donor stem cell transplant

FDA cautioned Friday that azithromycin (Zithromax, Zmax) should not be given long-term to prevent bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant.

FDA cautioned Friday that azithromycin (Zithromax, Zmax) should not be given long-term to prevent bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. There was a higher rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients, according to a clinical trial. Bronchiolitis obliterans syndrome is a lung condition caused by inflammation and scarring in the airways of the lung, leading to severe shortness of breath and dry cough. Cancer patients who undergo donor stem cell transplants are at risk for this condition. FDA said the manufacturer of brand name azithromycin is sending a Dear Healthcare Provider letter on this safety issue to health care professionals who treat patients undergoing donor stem cell transplants. The agency also noted that azithromycin, which is approved to treat many types of infections affecting the lungs, sinuses, and other parts of the body, is not approved for preventing bronchiolitis obliterans syndrome. Patients who have had a stem cell transplant should not discontinue azithromycin without first talking to their health care professional.