ADR that result in revision of patient information
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| The United States: Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms |
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The Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of FDA’s review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
The azithromycin drug labels have been updated to strengthen the Warnings and Precautions section with information related to the risk of QT interval prolongation and torsades de pointes, a specific, rare heart rhythm abnormality. Information has also been added regarding the results of a clinical QT study which showed that azithromycin can prolong the QTc interval.
FDA previously released a Statement on May 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The study reported an 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. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
FDA advised that healthcare professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events. FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm343350.htm
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 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 same day. The matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Department of Health will remain vigilant on any safety updates of the drug.
Ends/ Wednesday, March 13, 2013
Issued at HKT 13:00
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