The Therapeutic Goods Administration (TGA) has issued a safety update for azithromycin. New warnings have been added to the azithromycin product information and consumer medicine information documents regarding a transient increased risk of cardiovascular death.

These warnings were added following a review by the Advisory Committee on Medicines. One large observational study included in the review compared azithromycin and amoxicillin. This study found that azithromycin was associated with a significantly higher hazard of cardiovascular death (hazard ratio 1.82: 95% CI: 1.23-2.67) within five days of use.

The TGA advises that the risk of cardiovascular death associated with azithromycin is rare. Based on the available information, it is also not possible to establish or exclude causality. However, due to the seriousness of the event, a screening ECG should be considered for patients with a high risk of prolonged QT.

Azithromycin is available in oral preparations for the treatment of infections such as respiratory tract infections, uncomplicated skin and skin structure infections, acute streptococcal pharyngitis/tonsillitis, and Chlamydia trachomatis. The parenteral formulation is indicated for the treatment of community-acquired pneumonia.

References:

  1. Department of Health and Aged Care. Azithromycin and rare risk of cardiovascular death. Woden: Therapeutic Goods Administration; 2024.
  2. Zaroff JG, Cheetham TC, Palmetto N, Almers L, Quesenberry C, Schneider J, et al. Association of azithromycin use with cardiovascular mortality. JAMA Netw Open. 2020; 1: 3(6): e208199.

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