The Food and Drug Administration has issued a warning to the public that the antibacterial drug azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart, possibly leading to a potentially fatal arrhythmia.
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 arrhythmias.
The FDA's notice came after its review of a study by medical researchers and a study by a manufacturer of the drug that assessed the potential of azithromycin to cause abnormal changes in the electrical activity of the heart.
Azithromycin is marketed under the brand names Zithromax and Zmax. FDA-approved indications for azithromycin include acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, and genital ulcer disease.
Healthcare professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who already are at risk for cardiovascular events, according to the FDA.
However, the 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 fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered.
The FDA previously released a statement last May 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 with no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in people treated with a five-day course of azithromycin (Zithromax) compared with people treated with amoxicillin, ciprofloxacin or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
See a PDF of the FDA’s Drug Safety Communication, issued March 12: www.fda.gov/downloads/Drugs/DrugSafety/UCM343347.pdf.
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 arrhythmias.
The FDA's notice came after its review of a study by medical researchers and a study by a manufacturer of the drug that assessed the potential of azithromycin to cause abnormal changes in the electrical activity of the heart.
Azithromycin is marketed under the brand names Zithromax and Zmax. FDA-approved indications for azithromycin include acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, and genital ulcer disease.
Healthcare professionals should consider the risk of torsades de pointes and fatal heart rhythms with azithromycin when considering treatment options for patients who already are at risk for cardiovascular events, according to the FDA.
However, the 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 fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered.
The FDA previously released a statement last May 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 with no antibacterial drug. The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in people treated with a five-day course of azithromycin (Zithromax) compared with people treated with amoxicillin, ciprofloxacin or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
See a PDF of the FDA’s Drug Safety Communication, issued March 12: www.fda.gov/downloads/Drugs/DrugSafety/UCM343347.pdf.
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