FDA Warns Against Long-Term Azithromycin Use for Lung Condition in Cancer Patients

On August 3, the Food and Drug Administration issued a warning against the long-term use of the antibiotic azithromycin (Zithromax, Pfizer Inc.) 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. The FDA is reviewing additional data and will communicate its conclusions and recommendations when its review is complete.

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.

Azithromycin is not approved for preventing bronchiolitis obliterans syndrome; there are no known effective antibiotic treatments for prophylaxis of bronchiolitis obliterans syndrome. 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.

Read the full FDA warning here.

Posted 8/3/2018