Azithromycin safety; Is it safe for heart ? Answer from FDA

Azithromycin safety; Is it safe for heart ? Answer from FDA

Azithromycin safety is an antibiotic useful for the treatment of a number of bacterial infections. This includes middle ear infections, strep throat, pneumonia, traveler’s diarrhea, and certain other intestinal infections.[2] It may also be used for a number of sexually transmitted infections including chlamydia and gonorrhea infections. Along with other medications, it may also be used for malaria. It can be taken by mouth or intravenously with doses once per day.

Common side effects include nausea, vomiting, diarrhea and upset stomach. An allergic reaction or a type of diarrhea caused by Clostridium difficile is possible. No harm has been found with its use during pregnancy.Its safety during breastfeeding is not confirmed, but it is likely safe. Azithromycin is an azalide, a type of macrolide antibiotic. It works by decreasing the production of protein, thus stopping bacterial growth.

FDA WARNS AZITHROMYCIN “Z-PACK” ANTIBIOTICS COULD LEAD TO DEADLY HEART RHYTHMS STUDY CONFIRM

www.rxharun.com

Azithromycin, a commonly-prescribed antibiotic, may trigger a potentially deadly irregular heart rhythm for some patients, the Food and Drug Administration (FDA) warned Tuesday.

The antibiotic that’s sold as Zithromax, Zmax or sometimes referred to as a “Z-Pack” is prescribed to treat bacterial infections such as bronchitis, pneumonia, or ear infections.

The FDA is warning the public that the pills can cause abnormal changes in the heart’s electrical activity that may lead to a fatal heart rhythm. Not everyone is at risk. Patients with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or those who use  certain drugs to treat abnormal heart rhythms, or arrhythmias face the greatest risk.

“Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events,” the FDA said in its March 12th update.

You Might Also Like   OnabotulinumtoxinA; Uses, Dosage Side Effects, Interactions

The new guidance was prompted by a May 2012 study and another study by the antibiotic’s manufacturer, Pfizer, that looked at risks to electrical activity of the heart in azithromycin-takers.

Last May, a New England Journal of Medicine study paid for by the National Heart, Lung and Blood Institute found there would be 47 extra heart-related deaths per one million course of treatment with five days of Zithromax, as compared to 10 days of amoxicillin and other antibiotics. The risks of cardiovascular death associated with levofloxacin (Levaquin) treatment were similar to those associated with azithromycin treatment, according to the FDA.

Related image

  • Zithromax antibiotics tied to rare heart risks

“People need to recognize that the overall risk is low,” Dr. Harlan Krumholz, a Yale University health outcomes specialist who was not involved in the study, told the Associated Press last May. He added more research was needed but patients with heart disease “should probably be steered away” from Zithromax for now.

The FDA also issued a statement last May following the study saying the agency was aware of the findings, and it would review the results and communicate any new information.

Sales of Zithromax, one of the U.S.’ top-selling antibiotics, totaled $464 million in 2011 according to health care information company IMS Health, the AP reported.

References

  1.  Burton M, Habtamu E, Ho D, Gower EW (2015). “Interventions for trachoma trichiasis”Cochrane Database Syst Rev11: CD004008. doi:10.1002/14651858.CD004008.pub3PMC 4661324Freely accessiblePMID 26568232.
  2. Gonococcal Infections – 2015 STD Treatment Guidelines”Archivedfrom the original on 2016-03-01.
  3. The Guardian newspaper: ‘Super-gonorrhoea’ outbreak in Leeds, 18 September 2015 Archived 18 September 2015 at the Wayback Machine.
  4. Lippincott Illustrated Reviews : Pharmacology Sixth Edition. p. 506.
  5. “US azithromycin label” (PDF). FDA. February 2016. Archived (PDF)from the original on 2016-11-23.
  6. Mori F, Pecorari L, Pantano S, Rossi M, Pucci N, De Martino M, Novembre E (2014). “Azithromycin anaphylaxis in children”Int J Immunopathol Pharmacol27 (1): 121–6. doi:10.1177/039463201402700116PMID 24674687. Retrieved 19 February 2016.
  7. “Antibiotics and oral contraceptive failure — a case-crossover study”Contraception83 (5): 418–25. doi:10.1016/j.contraception.2010.08.020PMC 3326585PMID 21477683.
  8. Denise Grady (May 16, 2012). “Popular Antibiotic May Raise Risk of Sudden Death”The New York TimesArchived from the original on May 17, 2012. Retrieved May 18, 2012.
  9. Ray, Wayne A.; Murray, Katherine T.; Hall, Kathi; Arbogast, Patrick G.; Stein, C. Michael (2012). “Azithromycin and the Risk of Cardiovascular Death”New England Journal of Medicine366 (20): 1881–90. doi:10.1056/NEJMoa1003833PMC 3374857 PMID 22591294.
  10. FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms”. FDA. March 12, 2013. Archivedfrom the original on October 27, 2016.

Urine Analysis / Urinalysis

You Might Also Like   Is Diclofenac Better Than Ibuprofen For Back Pain, Yes

About the author

Translate »