Zithromax, widely known as a Z-Pak, is a powerful antibiotic manufactured by pharmaceutical giant Pfizer. The active ingredient in Zithromax is azithromycin. It is designed to travel deep into the body’s infected tissue and release slowly over time. In some cases, Zithromax can be taken for as little as one day, as opposed to other antibiotics which require a week or longer.
In 2001, Zithromax received FDA approval as a single-dose or three-day treatment for acute otitis media in children. Acute otitis media is infection and inflammation of the middle ear, just behind the patient’s eardrum. While Zithromax has provided adult and pediatric patients with fast infection relief, it has also caused serious side effects. The FDA issued a warning explaining the increased risk of fatal heart conditions from Zithromax use.
What Is Zithromax?
Azithromycin belongs to a medication class called macrolide antibiotics. Azithromycin is designed to stop bacterial growth within the body. It can be used to treat several bacterial infections, but not the flu, colds, or other viral infections.
Zithromax comes in tablet and liquid forms and can be used to treat several types of infections in adults and certain infections in children. The drug is FDA-approved to treat pediatric ear infections, pneumonia, and throat infections such as strep throat.
Zithromax can be used to treat adult conditions such as:
- Sinus infections
- Ear infections
- Skin infections
- Gastrointestinal infections such as traveler’s diarrhea
- Throat infections such as strep throat and tonsillitis
- Lung infections such as pneumonia and bronchitis
- Sexually transmitted infections such as gonorrhea
Zithromax for Bacterial Infections
Zithromax was developed to treat bacterial infections only. It cannot be used to treat viral infections such as the flu, stomach flu, or the common cold. Zithromax is primarily intended for treatment in adults. However, the drug has received FDA approval to treat certain conditions in children as well.
Zithromax is used to treat conditions such as:
- Sinus infections, or sinusitis
- Skin infections including folliculitis, cellulitis, and impetigo
- Ear infections, or otitis media
- Pelvic inflammatory disease (PID)
- Gastrointestinal infections including traveler’s diarrhea
- Lung infections including pneumonia and bronchitis
- Throat infections including tonsillitis and strep throat
Sexually Transmitted Infections (STIs)
Zithromax can also be used to treat certain types of sexually transmitted infections (STIs). Sexually transmitted infections are a group of infections transmitted most frequently through sexual contact. These infections are often mistakenly referred to as sexually transmitted diseases (STDs). Zithromax can be used to treat STIs such as gonorrhea, chlamydia, and chancroid.
Pediatric Zithromax Use
In 2001, the FDA approved Zithromax use in children’s ear infections, or acute otitis media. Children with ear infections may receive Zithromax as a single-dose or on a three-day treatment regimen. Acute otitis media is an infection of the middle ear, which is located behind the eardrum.
Directions for Zithromax Use
Recommended dosages of Zithromax use depend on several conditions. These conditions include the type of infection being treated, the health of the patient, the severity of the infection, and form of medication being used. Zithromax is available in tablets or regular-release oral suspension. Patients can take the drug with or without food. However, it is recommended that patients take the extended-release oral suspension on an empty stomach, roughly one to two hours before each meal.
In cases of pelvic inflammatory disease or severe pneumonia, Zithromax can be administered via injection. This form of Zithromax use typically occurs in a hospital under the direct supervision of a medical professional.
Adverse Effects of Zithromax Use
Like any prescription medication, there is a chance of side effects associated with taking Zithromax. These side effects range from mild to severe. Anaphylaxis is a serious side effect that can occur following Zithromax use. Anaphylaxis is a severe allergic reaction that presents as an itchy rash, swelling of the throat, and low blood pressure. If left untreated, anaphylaxis can be fatal due to its rapid onset associated with anaphylaxis.
Side effects associated with Zithromax use include:
- Abdominal pain
- Dermatologic reactions
Zithromax & Heart Problems
Zithromax is a prescription antibiotic medication for treating several types of infection. Its active ingredient is azithromycin, which is a member of a class of drugs called macrolides. Azithromycin is a powerful antibiotic that helps to decrease treatment duration for patients. Instead of a typical one-to-two-week treatment process, azithromycin can cure infections in as little as one day.
Zithromax is known to cause dangerous changes in the heart’s electrical system. The U.S. Food and Drug Administration (FDA) released a warning in March 2013 warning users of possible Zithromax heart problems, such as arrhythmia. Zithromax arrhythmia is a heart condition during which the patient’s heart beats in an irregular pattern. In severe cases, Zithromax arrhythmia can lead to death. Zithromax heart problems are a particular concern for users who already experience cardiovascular symptoms.
Risk factors for Zithromax arrhythmia include preexisting heart conditions. Patients with low blood potassium or magnesium levels are at-risk for Zithromax heart problems. Patients are also at-risk if they have a heart rate that is slower than normal. Those who use certain medications to treat abnormal heart rhythms may also experience Zithromax heart problems.
QT Interval Prolongation
QT interval prolongation is a disorder of the heart’s electrical cycle. The QT interval is the time duration between the start of the heart’s Q wave and the end of its T wave. Essentially, the QT interval measures the depolarization and repolarization that takes place in the heart’s ventricles. QT interval prolongation is associated with decreased heart rate. These prolonged QT intervals can typically be detected using diagnostic machines such as electrocardiogram (ECG).
Torsades de Pointes
Torsades de pointes is a rare and specific type of heart problem that results in ventricular tachycardia, or increased heart rate. This condition is associated with QT interval prolongation. Torsades de pointes translates from French to “twisting of the spikes.” Torsades de pointes is associated with a sharp decrease in the patient’s arterial blood pressure. This can cause syncope, or fainting.
In some cases, torsades de pointes can degenerate into a condition called ventricular fibrillation. Ventricular fibrillation results in uncoordinated contractions in the ventricular muscles. This can then lead to cardiogenic shock and a lack of proper blood circulation. If the patient does not receive immediate medical attention, sudden death can occur.
Zithromax Heart Problem Studies
In May 2012, the New England Journal of Medicine published a study exploring Zithromax heart problems in comparison to other types of antibiotics. The study revealed that azithromycin significantly increased the risk of cardiovascular death in comparison to other antibiotics including amoxicillin, ciprofloxacin, and levofloxacin. Patients treated with a five-day azithromycin cycle showed a higher risk of cardiovascular death than those treated with ciprofloxacin, amoxicillin, or no antibiotic. In healthy patients, the risk of cardiovascular death was one in 111,000. In high-risk patients, the risk drastically increased to one in 4,100.
In 2013, Zithromax manufacturer Pfizer added Zithromax heart problems to the drug’s Warning and Precautions label section. The label now includes the risk of developing QT interval prolongation and torsades the pointes. The label also includes information from a clinical study which reveals that azithromycin can prolong a patient’s QTc inverval, or corrected QT interval.
Azithromycin FDA Precautions
The FDA cautions health care professionals to take certain considerations before prescribing Zithromax and other drugs that can cause heart problems. Special consideration should be given to patients who exhibit preexisting risk for cardiovascular events. Other drugs in the macrolide drug class may increase heart problem risks. Additionally, non-macrolide drugs such as fluoroquinolones are also known to cause heart problems in high-risk patients.
In 2013, the FDA stated that Zithromax use could lead to abnormal changes in the heart’s electrical activity. These changes could potentially cause a patient to have an irregular heart rhythm that could lead to death. Earlier in 2012 the FDA had also noted that Zithromax could increase the risk of death in patients, particularly those with previous heart conditions.
Specifically, the FDA reported that those with the following preexisting conditions are at a particular risk of irregular heart rhythm or death:
- QT interval prolongation
- Low blood levels of magnesium
- Low blood levels of potassium
- Slower than normal heart rate
- Patients that use specific drugs to treat abnormal heart rhythms or arrhythmias
Studies such as the one conducted by Dr. Ray suggest that Zithromax is a powerful antibiotic that needs to be carefully administered. Other experts in the field, including Dr. Bartlett, former president of the Infectious Diseases Society of America, suggest doctors are too quick to prescribe Zithromax. In a recent New York Times article, Dr. Bartlett noted that Zithromax was used for too many things.
Additionally, he asserted that our medical system abuses it badly. Dr. Bartlett claimed: “For most of where we use it, probably the best option is not to give an antibiotic.” Zithromax is often prescribed for colds and other viral infections that it is not meant to treat. Overuse of Zithromax can lead to more dangerous, drug-resistant strains of bacteria.
Zithromax Side Effects
Zithromax is an antibiotic prescription. It is Pfizer’s brand-name version of azithromycin and is commonly known as a Z-Pak or Zmax. Zithromax was created in the early 1980s by Pliva, a Croatian pharmaceutical company, who licensed rights to Pfizer. It was later approved by the U.S. Food and Drug Administration (FDA) in the mid 90s. Zithromax is prescribed for the treatment of bacterial infections.
Zithromax works by inhibiting the bacteria’s protein production, which slows down bacterial growth. By slowing bacterial growth, this drug gives antibodies an advantage when fighting off the infection, so the patient is more likely to recover. According to the FDA, 40.3 million people in the U.S. received outpatient prescriptions for Zithromax in 2011. This generated over $400 million in revenue for Pfizer.
FDA-approved applications for Zithromax include:
- Community-acquired pneumonia
- Skin infections
- Acute bacterial sinusitis
- Acute bacterial exacerbations of chronic pulmonary disease
- Pharyngitis or tonsillitis
- Urethritis and cervicitis
- Genital ulcer disease
Common Zithromax side effects may be minor, but aggravating, and they include:
- Upset stomach
- Nausea or vomiting
- Pain at injection site
- Stomach pain or discomfort
FDA Warning Statements
Zithromax belongs to a class of antibiotics known as macrolides. These antibiotics have been associated with life-threatening cardiovascular conditions in adults. In March 2012, Pfizer updated the warning label on Zithromax to include QT interval prolongation within the Zithromax side effects list. This change came after an FDA investigation in 2011, in conjunction with studies done on macrolides and life-threatening cardiovascular conditions.
Life-Threatening Zithromax Side Effects
The FDA cites a study done in the New England Journal of Medicine published on May 17, 2012. The study compared patients’ risk for cardiovascular death when treated separately with azithromycin (Zithromax,) amoxicillin, ciprofloxacin (Cipro,) levofloxacin (Levaquin), and a control group without any antibiotic treatment. The published research concluded patients receiving Zithromax and Levaquin had the highest risk of cardiovascular death.
Specifically, recent studies on Zithromax side effects point to cardiovascular conditions such as QT interval prolongation and torsades de pointes (TdP). Life-threatening Zithromax side effects were also reported in an FDA safety announcement dated March 12th, 2013. The FDA research indicated Zithromax caused irregular heart rhythm due to the drug’s abnormal effect on the heart’s electrical activity.
Zithromax Risk Factors
Fatal irregular heart rhythms associated with Zithromax side effects were more prevalent in patients with risk factors such as:
- QT interval prolongation
- Low levels of potassium or magnesium
- Slower than normal heart rate
- Taking other drugs for abnormal heart rates or arrhythmias
Lawsuits against Pfizer
Zithromax side effects are also the subject of numerous class action lawsuit investigations against Pfizer in the wake of the FDA’s statements. These lawsuits focus on QT interval prolongation and torsades de pointes (TdP) as potentially fatal Zithromax side effects. Some attorneys claim these Zithromax side effects were not adequately investigated by Pfizer before the drug was out on the market. Attorneys filing these class action lawsuits are looking for individuals or family members who have experienced loss or personal injury due to life-threatening Zithromax side effects.
Zithromax comes in tablet form, with doses of 250 mg, 500 mg, and 600 mg. It also comes in powder for oral suspension with doses of 100 mg per 5 mL, 200 mg per mL, and 1 g single dose. In extreme cases of pneumonia or pelvic inflammatory disease, a doctor may administer a dose of the antibiotic via syringe injection. Prescription dosages may vary by case and are to be determined the doctor. Patients are warned to always complete their full Z-Pak and to never take double doses, even if a dose of Zithromax is missed.
Zithromax users should seek immediate medical attention at the onset of the following side effects:
- Bleeding gums
- Flu-like symptoms
- Severe diarrhea
- Black, tarry, or bloody stool
- Dark-colored urine
- Blurred vision
- Unusual bruising or bleeding
- Peeling, loosening, or blistering of the skin
- Unusual weight changes
- Changes in hearing
- Jaundice, or yellowing of the eyes and skin
- Irregular or decreased heart rate
Zithromax FDA Warning
In March 2013, the FDA issued a warning for Zithromax. The warning alerted consumers that Zithromax patients who are at risk for heart problems have an increased risk of arrhythmia, or irregular heart rhythm. At-risk patients include those who have low potassium or magnesium. Patients who have abnormally slow rates or take arrhythmia drugs are also at-risk for heart problems.
FDA warnings were prompted by a study that was featured in the New England Journal of Medicine. The study revealed that Zithromax users faced an increased risk of mortality within five days of beginning treatment. Vanderbilt University researchers discovered that death from cardiovascular complications was 2.5 times more likely in Zithromax users as compared to amoxicillin users.
Patients who have been injured from Zithromax may be eligible to file a lawsuit against Pfizer. Zithromax victims may be entitled to financial compensation to cover the costs of medical bills, lost wages, pain, and suffering. In the case of a death from Zithromax, family members may be able to file a wrongful death claim to receive compensation for their loss.
Zithromax patients or family members who wish to file a claim against Pfizer should seek a knowledgeable and experienced attorney immediately. An attorney can help to discuss legal options and pursue the best course of action for each individual case.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.