Warnings about Z-Pak: What You Need to Know About This Antibiotic

If you’re like many people across the country, you would have been prescribed a course of azithromycin at some stage — that is, an antibiotic commonly referred to as Z-Pak, Zmax, or Zithromax. However, while the drug has been given to millions of patients over the years, there are numerous risks that have been associated with the medication that consumers need to know about. Read on for the rundown on this antibiotic today.

Description of the Drug

Azithromycin, marketed under a variety of different brand names, is a broad-spectrum, semisynthetic antibiotic that belongs to a group of antibiotics called macrolides. It was released in the early 1990s and is one of the most frequently-used antibiotics in the United States (and is very popular in many other nations). In 2011, for instance, more than 40 million people in the U.S. received an outpatient prescription for the medication.

The drug is used to treat a number of conditions, but particularly bacterial ones. It is commonly prescribed to treat respiratory, ear, throat, and other infections such as tonsillitis, pharyngitis, acute bacterial sinusitis, community-acquired pneumonia, cervicitis, urinary tract infections (UTIs), acute bacterial exacerbations of chronic obstructive pulmonary disease, genital ulcer disease, sexually transmitted diseases, and uncomplicated skin and soft tissue infections. The medication can be used alone or in combination with other prescriptions.

Azithromycin is usually administered orally, but for people who are unable to tolerate drugs taken this way, an intravenous formulation does exist. The medication is considered safe to use in pregnancy and breastfeeding, although it can cause diarrhea in breastfeeding infants.

The duration of treatment varies quite a bit according to the indication and severity of infection, so patients should follow their doctor’s recommendations. However, as a guideline, a single dose is often recommended for sexually transmitted infections, while several days’ worth of the medication is usually considered appropriate for respiratory tract infections. For people suffering from mycobacterial infections, a number of months of treatment may be suggested.

It is important that patients tell their physician about any relevant health history/issues before they start taking azithromycin. For example, tell your doctor if:

  • You are currently ill or taking any other medications
  • You are allergic to any other medicines or any particular foods or drinks
  • You have any known long-term health conditions, especially heart, kidney ,or liver problems

How These Antibiotics Work

Azithromycin works by reversibly binding to the bacterial ribosome and inhibiting protein synthesis. Basically, the medication kills the bacteria that cause an infection such as pneumonia, whooping cough, or a UTI. It stops the bacteria from multiplying by preventing the bacterial cell from carrying out the essential functions which are necessary for life — that is, making protein building blocks for the cells.

Potential Side Effects

Although azithromycin in its different brand forms is generally well tolerated by patients, there are a number of adverse effects which can occur as a result of taking the medication. This list includes things such as:

  • Headaches
  • Dizziness
  • Gastrointestinal upsets like diarrhea, stomach pain, cramps, nausea, and vomiting
  • Hearing loss or impairment
  • Ringing in the ears (tinnitus)
  • Slowed heart rate or fatal heart rhythms
  • Antibiotic resistance
  • Thrush (Candida infection)
  • Rashes
  • Allergic reactions such as hives, fever, fainting, breathing problems, or swollen lips, tongue, or mouth
  • Inflamed pancreas
  • Cholestatic hepatitis (liver issue)
  • An infection with another bacteria
  • Skin sensitivity to sunlight (with a development of a rash, redness and/or itching)

FDA Warnings

In May 2012 the United States Food and Drug Administration (FDA) released a statement about a study by the New England Journal of Medicine that compared the risks of cardiovascular death in patients treated with various types of antibacterial drugs, including azithromycin, or no antibacterial drug at all.

The findings of the study showed that people who were treated with a 5-day course of azithromycin were at an increased risk of cardiovascular death, and death from any cause, than those who were treated with no drug at all or with most other studied antibiotics such as amoxicillin or ciprofloxacin. (Note that the risks involved in taking levofloxacin were seen to be similar to those associated with azithromycin.)

As a result of this study, the FDA issued a warning to the public that taking azithromycin can cause abnormal changes in the electrical activity of the heart. These changes could lead to an irregular heart rhythm that can be potentially fatal. In particular, patients with known risk factors, such as low blood levels of potassium or magnesium, an existing QT interval prolongation, a slower-than-normal heart rat, or taking certain drugs used to treat arrhythmias (abnormal heart rhythms), are at higher risk of developing the heart condition.

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