FDA Releases Safety Communication on Azithromycin
August 3, 2018 – The U.S. FDA has issued a warning that the antibiotic azithromycin should not be used long-term to prevent bronchiolitis obliterans syndrome, an inflammatory condition of the lungs, in patients who have cancers of the blood or lymph nodes and undergo a donor stem cell transplant.
In clinical trials, patients who were diagnosed with blood or lymph node cancers and received azithromycin long term had an increased incidence of relapse and mortality. Azithromycin, available in generic forms and from Pfizer under the brand names Zithromax® and Zmax®, was being studied to determine its applications in preventing bronchiolitis obliterans syndrome. The condition causes scarring and inflammation of the airways, which leads patients to develop a cough and severe shortness of breath. Bronchiolitis obliterans syndrome is a known risk for patients with cancer who undergo stem cell transplants.
The prevention of bronchiolitis obliterans syndrome is not an FDA-approved indication for azithromycin. However, the drug is indicated to treat numerous infections, including infections caused by various Staphylococcus and Streptococcus species. It was first approved for use in the United States in 1991.