ISSUE 4 AUGUST
Summary
An updated warning about the risk of sudden cardiovascular death has been added to the Product Information (PI) and Consumer Medicine Information (CMI) documents for azithromycin.
Azithromycin already carried a warning of ventricular arrhythmias associated with prolonged QT interval. The update describes an increased short-term risk of cardiovascular death with azithromycin compared to other antibacterial drugs, including amoxicillin. This risk is rare but appears to be greater during the first 5 days of azithromycin use.
The new warning also advises that healthcare professionals should consider a screening ECG in patients at high risk of a prolonged QT, based on their medical history or ongoing medical treatments.
The update was made following a recommendation from the Advisory Committee on Medicines. This was based on the Committee’s review of published literature including observational studies, the seriousness of the adverse event and updated warnings by the Food and Drug Administration in the US.
The Committee noted that the information in the observational studies was insufficient to establish or exclude a causal relationship between acute cardiovascular death and azithromycin use due to inconsistent results between studies.
See the full article on the TGA website.
Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 1 August 2024.
