FDA News

FDA warns against use of azithromycin following stem cell transplant

The FDA issued a warning that azithromycin should not be administered long term to prevent bronchiolitis obliterans syndrome among patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant.

Prescribing azithromycin may cause increased risk for cancer relapse and death among these patients, according to the FDA.

Bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs and can result in shortness of breath and dry cough. Patients with cancer who undergo stem cell transplants are at an increased risk for this inflammatory lung condition.

Researchers evaluated use of azithromycin — an antibiotic, also sold under the brand names Zithromax and Zmax (Pfizer) — for the treatment of bronchiolitis obliterans syndrome. Azithromycin is not approved for this indication.

The ALLOZITHRO trial, which assessed long-term azithromycin exposure among patients who underwent allogenic hematopoietic stem cell transplantation, was terminated early due to an increased risk for relapses.

In a statement, the FDA warned health care professionals against prescribing long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome among patients with cancer who underwent HCST. Azithromycin may cause an increased risk for cancer relapse and death, according to the FDA.

Patients taking azithromycin should not stop taking the antibiotic without first consulting with their health care professional.

Azithromycin is approved to treat many types of infections including those affecting the lungs, sinuses and skin.

The FDA issued a warning that azithromycin should not be administered long term to prevent bronchiolitis obliterans syndrome among patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant.

Prescribing azithromycin may cause increased risk for cancer relapse and death among these patients, according to the FDA.

Bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs and can result in shortness of breath and dry cough. Patients with cancer who undergo stem cell transplants are at an increased risk for this inflammatory lung condition.

Researchers evaluated use of azithromycin — an antibiotic, also sold under the brand names Zithromax and Zmax (Pfizer) — for the treatment of bronchiolitis obliterans syndrome. Azithromycin is not approved for this indication.

The ALLOZITHRO trial, which assessed long-term azithromycin exposure among patients who underwent allogenic hematopoietic stem cell transplantation, was terminated early due to an increased risk for relapses.

In a statement, the FDA warned health care professionals against prescribing long-term azithromycin for prophylaxis of bronchiolitis obliterans syndrome among patients with cancer who underwent HCST. Azithromycin may cause an increased risk for cancer relapse and death, according to the FDA.

Patients taking azithromycin should not stop taking the antibiotic without first consulting with their health care professional.

Azithromycin is approved to treat many types of infections including those affecting the lungs, sinuses and skin.