FDA Warns of Increased Risk of Cancer Relapse With Certain Long-Term Uses of Azithromycin
The US Food and Drug Administration (FDA) on Thursday warned that the antibiotic azithromycin (Zithromax, Zmax) should not be given long-term to prevent a certain inflammatory lung condition, known as bronchiolitis obliterans syndrome, in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant.“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,” FDA said.
The warning comes as researchers in France identified an increased risk of cancer relapse and death while conducting a clinical trial on the effectiveness of long-term azithromycin to prevent bronchiolitis obliterans syndrome in patients who undergo donor stem cell transplants for cancers of the blood and lymph nodes.
“The researchers concluded that the risks of long-term azithromycin exposure after donor stem cell transplantation may exceed the benefits. The trial could not determine why the rates of cancer relapse and death were higher with azithromycin,” FDA said.
The trial was halted, according to FDA, about 13 months after the study completed enrollment because an unexpected increase in the rate of both cancer relapses and death was observed in patients taking azithromycin.
FDA