FDA Warning about Zithromax, Zmax

PUBLISHED: Aug 3, 2018
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) is warning health care providers that the antibiotic Zithromax, Zmax (azithromycin,) should not be given long-term 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 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. It is an FDA-approved antibiotic used to treat many types of infections affecting the lungs, sinuses, skin, and other parts of the body. The drug has been used for more than 26 years. It is sold under the brand names Zithromax and Zmax and as generics by many different drug companies. It works by stopping the growth of bacteria that can cause infections.

The manufacturer of brand name azithromycin has provided a Dear Healthcare Provider letter on this safety issue to health care professionals who care for patients undergoing donor stem cell transplants, which can be accessed by following the link below.

The FDA is reviewing additional data and will communicate their conclusions and recommendations when that review is complete.

The FDA recommends the following:

  • 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.
  • Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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