Other safety alerts
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| The United States: Zithromax (azithromycin): FDA Statement on risk of cardiovascular death |
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FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
FDA recommended that patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm304503.htm
In Hong Kong, there are 61 registered pharmaceutical products containing azithromycin and are prescription-only medicines. Regarding to FDA’s present recommendation, a letter to inform healthcare professionals will be issued. Since the study is still under FDA’s review, Department of Health will keep vigilance against any updated issues released by FDA and other regulatory authorities.
Ends/Friday, May 18, 2012
Issued at HKT 13:00 |
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