March 12, 2013 Audience: Family Practice, Individual, Drugstore, Medical Expert ISSUE: FDA is warning the public that azithromycin (Zithromax or Zmax) can cause irregular changes in the electrical activity of the heart that might lead to a potentially lethal abnormal heart rhythm. Individuals at particular risk for developing this problem include those with known risk factors such as existing QT interval prolongation, reduced blood levels of potassium or magnesium, a than normal heart rate, or use of certain medications used to handle abnormal heart rhythms, or arrhythmias.A FDA has issued a Safety Communication today as a result of our evaluation of a study by medical scientists as well as another study by a manufacturer of the drug that considered the potential for azithromycin to cause abnormal changes in the electrical action of the heart. Food previously launched a Statement on May possibly 17, 2012, about a study that compared the risks of cardiovascular death in patients treated with the antibacterial medicines azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug. The analysis reported a rise in cardiovascular fatalities, and in the chance of death from any cause, in persons treated with a 5-day length of azithromycin (Zithromax) in comparison to persons treated with amoxicillin, ciprofloxacin, or no drug. The pitfalls of cardiovascular death associated with levofloxacin treatment were just like those associated with azithromycin treatment. BACKGROUND: Azithromycin is sold under the brands Zithromax and Zmax. Change to aFDA-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, genital ulcer disease RECOMMENDATION: Healthcare professionals should consider the risk of torsades de pointes and dangerous heart rhythms with azithromycin when considering treatments for people who're already at risk for cardiovascular events.A FDA notes that the potential risk of QT prolongation with azithromycin should be put in appropriate context when choosing an drug: Alternative medications in the macrolide class, or non-macrolides including the fluoroquinolones, likewise have the potential for QT prolongation or other important unwanted effects that should be considered when choosing an antibacterial substance. Healthcare professionals and clients are encouraged to report adverse events or side effects associated with the use of the products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: [03/12/2013 -Drug Safety Communication - FDA][05/17/2013 - Statement - FDA] View responses
No comments:
Post a Comment