Research shows the antibiotic known generically as azithromycin and sold under the brand names Zithromax, Zmax, and Z-Pak might cause fatal heart-related side effects. In fact, studies show that patients who take Zithromax are considerably more likely than non-antibiotic patients and patients on other antibiotics to die from heart-related injuries and other causes.
What Is Zithromax? When Is It Prescribed?
Zithromax is the brand name for the drug azithromycin. The Croatian pharmaceutical company Pliva first discovered it in the early 1980s, and later it licensed the American pharmaceutical giant Pfizer, Inc. to sell Zithromax in the United States and elsewhere. Zithromax is indicated to treat bacterial infections including:
- chronic pulmonary disease
- community-acquired pneumonia
- pharyngitis and tonsillitis
- uncomplicated skin infections
- urethritis and cervicitis
- genital ulcer disease
The U.S. Food and Drug Administration (FDA) approved Zithromax in July 1996, and doctors prescribe it in either oral tablets or oral suspensions. Azithromycin is one of the most widely prescribed drugs in the United States, with 48.5 million prescriptions sold in 2010, totaling $912.2 million in revenue.
A member of the “azalide” subclass of “macrolide” antibiotics, Zithromax works by interfering with certain bacteria’s protein creation processes. By doing this, Zithromax slows bacteria growth, which allows the body’s natural defenses to defeat them.
Zithromax Might Cause Fatal Heart-Related Side Effects
On May 17, 2012, the FDA released a statement regarding Zithromax cardiovascular side effects. Citing research published in the New England Journal of Medicine (NEJM) in May 2012, the agency claimed it would review the results and release additional instructions.
The NEJM study compared large numbers of people who suffered bacterial infections and used azithromycin (347,795), amoxicillin (1,348,672), ciprofloxacin (Cipro) (264,626), levofloxacin (Levaquin) (193,906), or no antibiotics (1,391,180) to treat the conditions. The researchers found that during five days of therapy, the Zithromax users were 2.88 times more likely than non-antibiotic patients to die from heart-related side effects. Against amoxicillin, Zithromax users were 2.49 times more likely to die of cardiovascular side effects and 2.02 times more likely to die from other causes. The researchers calculated that compared to amoxicillin, Zithromax use corresponded to 47 heart-related deaths per million treatment courses. The risk of Zithromax death was comparable to that of Levaquin.
In its statement, the FDA characterized the increased risk as “small,” and it noted that the drug label for Zmax, the Zithromax extended oral suspension product, changed in March 2012 to include a QT interval prolongation entry in its “Warnings and Precautions” section.
Zithromax QT Interval Prolongation Symptoms
One Zithromax cardiovascular side effect the FDA is concerned about in particular is called “QT interval prolongation.” The QT interval is a segment of the human heartbeat as defined in terms of electrical pulses. QT interval prolongation can indicate a type of irregular heartbeat called “Torsades de Pointes,” a potentially fatal condition. As a type of ventricular tachycardia (accelerated heartbeat), Torsades de Pointes’ symptoms include:
- ventricular fibrillation (the uncoordinated contraction of the cardiac muscle of the heart’s ventricles)
- cardiac arrest
- sudden death
On March 12, 2013, the FDA announced it had concluded its review of the NEJM study and issued a drug safety communication stating that it largely agreed with the researchers’ findings. Although the agency found some flaws in with the methodology used in the NEJM study, it determined that healthy patients who use the antibiotics faced a 1 in 111,000 risk of experiencing a cardiac-related side effect, but patients with known heart problems faced a 1 in 4,100 risk of suffering a heart-related problem. In response, the FDA updated the Zithromax drug label by adding that the drug was known to prolong patients’ QT intervals.
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Zithromax lawsuit on your behalf if necessary.
If you have taken Zithromax and believe it harmed you, contact RLG today.