[Posted 03/12/2013] 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. 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. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Azithromycin is used to treat certain bacterial infections, such as bronchitis; pneumonia; sexually transmitted diseases (STD); and infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. Azithromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics will not kill viruses that can cause colds, flu, or other infections.
Azithromycin comes as a tablet, an extended-release (long-acting) suspension (liquid) and a suspension (liquid) to take by mouth. The tablets and suspension (Zithromax) are usually taken with or without food once a day for 1 to 5 days. The extended-release suspension (Zmax) is usually taken on an empty stomach (at least 1 hour before or 2 hours after a meal) as a one-time dose. To help you remember to take azithromycin, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take azithromycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Shake the liquid well before each use to mix the medication evenly. Use a dosing spoon, oral syringe, or measuring cup to measure the correct amount of medication. Rinse the measuring device with water after taking the full dose of medication.
If you receive azithromycin extended-release suspension as a dry powder you must first add water to the bottle before you take the medication. Open the bottle by pressing down on the cap and twisting. Measure 1/4 cup (60 mL) of water and add to the bottle. Close the bottle tightly and shake well to mix.
Use the extended-release liquid within 12 hours of receiving it from the pharmacy or adding water to the powder.
If you vomit within an hour after taking azithromycin, call your doctor right away. Your doctor will tell you if you need to take another dose. Do not take another dose unless your doctor tells you to do so.
You should begin to feel better during the first few days of treatment with azithromycin. If your symptoms do not improve, or get worse, call your doctor.
Take azithromycin until you finish the prescription, even if you feel better. If you stop taking azithromycin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Azithromycin is also used sometimes to treat H. pylori infection, traveler's diarrhea, and other gastrointestinal infections; Legionnaires' disease (a type of lung infection); disseminated Mycobacterium avium complex (MAC) infection [a type of lung infection that often affects people with human immunodeficiency virus (HIV)]; pertussis (whooping cough; a serious infection that can cause severe coughing); and babesiosis (an infectious disease carried by ticks). It is also used to prevent heart infection in people having dental or other procedures, and to prevent STD in victims of sexual assault. Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
fast, pounding, or irregular heart beat
wheezing or difficulty breathing or swallowing
swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
yellowing of the skin or eyes
unusual bleeding or bruising
lack of energy
loss of appetite
pain in the upper right part of the stomach
blisters or peeling of the skin
unusual muscle weakness or difficulty with muscle control
Azithromycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store azithromycin tablets and suspension at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate or freeze the suspension. Throw away any unused azithromycin suspension after dosing is complete . Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to azithromycin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the azithromycin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 10/15/2012
AHFS® Consumer Medication Information. © Copyright, 2013. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.