UK Medicines Information
FDA warns about increased risk of cancer relapse with long-term use of azithromycin for prophylaxis of bronchiolitis obliterans syndrome after donor stem cell transplant
Information type:
Safety alerts
Source:
US Food and Drug Administration
Specialities:
Cancers | Infection and infectious diseases | Respiratory disorders | Surgery
Summary
This alert is based on results from the ALLOZITHRO RCT which was terminated early because of an increased risk of haematological relapses, a non pre-specified adverse event, and mortality in the azithromycin vs placebo (32.9% vs 20.8%; 2-year survival 56.6% vs 70.1%.
UKMi comment
Azithromycin is not approved for preventing bronchiolitis obliterans syndrome in the UK
Related links:
ALLOZITHRO RCT