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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY March 2013 | Archived Issues

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Risk of Potentially Fatal Heart Rhythms with Azithromycin (Zithromax or Zmax)

Pharmacy Focus

The U.S. Food and Drug Administration has strengthened a previous warning regarding a small but significant increased risk of fatal arrhythmias associated with azithromycin (marketed as Zithromax® or Zmax®). Also, the FDA is evaluating unpublished findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.

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Risk of Potentially Fatal Heart Rhythms with Azithromycin (Zithromax or Zmax)

Pharmacy Focus

FDA Strengthens Warning for Azithromycin 

The U.S. Food and Drug Administration has strengthened a previous warning regarding a small but significant increased risk of fatal arrhythmias associated with azithromycin (marketed as Zithromax® or Zmax®). The previous warning was released May 17, 2012, following publication of an article in the New England Journal of Medicine (see PDF link below) reporting a small but statistically significant increase in cardiovascular deaths in individuals treated with a five-day course of azithromycin (higher risk than placebo and "comparators" amoxicillin and ciprofloxacin; similar risk with levofloxacin), and specifically as a risk factor for development of Torsades de pointes and other arrhythmias.

Patients at higher risk for developing these malignant arrhythmias include those with known risk factors such as existing QT interval prolongation, hypokalemia or hypomagnesemia, bradycardia, or use of certain antiarrhythmic medications. The March 12, 2013, Drug Safety Communication was released following the FDA's review of the NEJM article as well as another study by a manufacturer of azithromycin that assessed the arrhythmogenic potential of the medication.

Healthcare professionals should consider the risk of Torsades de pointes and fatal arrhythmias 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.

Click here to read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication.

NEJM Article on Azithromycin (PDF)

Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Changes of the Pancreas with Incretin Mimetic Drugs for Type 2 Diabetes

FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.

Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. FDA will participate in a June workshop on pancreatitis, diabetes and pancreatic cancer – sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Cancer Institute –to gather and share additional information.

The Warnings and Precautions section of drug labels and patient medication guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics.

FDA recommends that patients continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels.

Click here to read the complete MedWatch Safety Alert.