Other safety alerts
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| Australia: Azithromycin and rare risk of cardiovascular death |
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The Therapeutic Goods Administration (TGA) announces that 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 electrocardiogram (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 United States.
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.
Health professionals should be aware of this potential adverse event so they can balance the benefits of azithromycin with the rare but serious risk of sudden cardiac death. Consider precautionary ECG screening for patients with a high risk of a prolonged QT.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/azithromycin-and-rare-risk-cardiovascular-death
In Hong Kong, there are 46 registered pharmaceutical products containing azithromycin, and all products are prescription-only medicines. So far, the Department of Health (DH) has received 8 cases of adverse drug reaction related to azithromycin, but these cases are not related to sudden cardiovascular death. Related news about risks of cardiac death was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 18 May 2012, with the latest update posted on 18 May 2013. Letters to inform local healthcare professionals were issued on 18 May 2012 and 20 May 2013. In Feb 2015, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack label and/or package insert of azithromycin products should include the relevant safety information. In light of the above TGA’s announcement, with updated warning about the risk of the sudden cardiovascular death, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, August 2, 2024
Issued at HKT 14:15
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