Moda Health. Healthcare from your head to your toes. Delta Dental | Moda Health

Azithromycin (Zithromax or Zmax): Drug Safety Communication - Risk of Potentially Fatal Heart Rhythms

Issue

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. FDA has issued a Drug Safety Communication today as a result of our 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.

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.

Background

Azithromycin is marketed under the brand names Zithromax and Zmax. Change to "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, genital ulcer disease."

Recommendation

Health care 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Moda Health Provider Network

Find a physician, pharmacy or clinic

Opt in for medical

Tell us you're interested and we'll be in touch with details.

Get Started  Get Started

Member Dashboard

Questions?

If you can't find an answer, please feel free to contact our Customer Service Customer Service Customer Service

Questions?

If you can't find an answer, please feel free to contact our Customer Service

Employer web tools

Benefit Tracker

Check benefits and eligibility

Log in

Account help

Request an account

Provider Reports

For value-based provider programs, including Synergy, Summit, Beacon, Affinity, CPC+, and EOCCO

Log in

Join our email list

Sign up

Benefit Tracker

Check benefits, eligibility, incentive and utilization

Log In

Account help

Create an account

Producer web tools


Hello.

We have exciting news to share. ODS is changing its name to Moda Health.

Moda comes from the latin term "modus" and means "a way". We picked it because that's what we are here to do: help our communities find a way to better health.

Together, we can be more, be better.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Hello.

Please select the state you live in, or the state where your employer is headquartered, so we can tailor your experience:

Changing your location to Oregon

You can return to your previous location in the site header.