ADR that result in revision of patient information
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| Singapore: Azithromycin and potential risk of QT prolongation |
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The Health Sciences Authority (HSA) announced that two recent research studies have strengthened the evidence regarding the potential risk of QT prolongation associated with the use of azithromycin. The first study suggested a higher risk of cardiovascular deaths and deaths from any cause in persons treated with a 5-day course of azithromycin compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The excess risk of cardiovascular death, especially of sudden death, was consistent with arrhythmias from drug-related QT prolongation. In the second study, co-administration of azithromycin with chloroquine increased the QTc interval in a dose- and concentration-dependent manner compared to chloroquine alone.
In the light of this latest data, healthcare professionals are advised to be aware of the risk of Torsades de Pointes and fatal arrhythmia when considering azithromycin as a treatment option for patients who are at risk for cardiovascular events. HSA is currently working with the relevant product licence holders to update the package inserts of all azithromycin products to strengthen the warnings regarding the risk of abnormal cardiac rhythms. Apart from azithromycin, other macrolides such as erythromycin and clarithromycin or non-macrolides such as the fluoroquinolones, are known to have the potential for QT prolongation or other significant side effects. Healthcare professionals are advised to take into consideration these factors when prescribing antibacterial treatment for their patients.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/publish/hsaportal/../azithromycin_and_potential.html
In Hong Kong, there are 62 registered pharmaceutical products containing azithromycin and are prescription-only medicines. Related news has been released by FDA and was posted on the website of Drug Office on 18 May 2012 and 13 March 2013. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on 18 May 2012. So far, the Department of Health has not received any related adverse reports in connection with the drug. As reported on 13 March 2013, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Monday, May 06, 2013
Issued at HKT 15:00
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