Zithromax, also known as Z-Pak, is a popular antibiotic manufactured by Pfizer Inc. for the treatment of mild to moderate infections. While it is reportedly popular because of its effectiveness as a antibiotic treatment, Zithromax has also been linked to an increase risk of liver and kidney damage and failure among its users.

First approved by the FDA in 1992, Zithromax is used to treat bacterial infections such as bronchitis, pneumonia, and infections of the ears, lungs and other organs. Recently, there have been reports of severe side effects from the Pfizer drug, including Zithromax liver and kidney damage, resulting in the need for transplant surgery for numerous patients.

The active ingredient in Zithromax is azithromycin. According to the Zithromax label, azithromycin is mainly eliminated from the patient’s system through the liver and kidneys, meaning that patients with liver or kidney problems could be at an increased risk of Zithromax side effects.

Zithromax and Liver/Kidney Failure

Zithromax is filtered out of the body by the liver and kidneys. The risk of damage to these organs is increased because the medicine is a particularly potent antibiotic medication. Because Zithromax is metabolized and processed in the liver, patients with liver problems or abnormal liver function may be at risk of serious problems from using this drug.

Hepatotoxicity (toxic liver disease) and hepatitis have been reported in patients taking Zithromax, occasionally resulting in death. Symptoms of organ damage from Zithromax include:

• Abdominal pain
• Fatigue
• Nausea and vomiting
• Clay-colored stools
• Dark urine
• Skin discoloration

Zithromax FDA Warning

Zithromax was approved by the FDA in June 1996. Pfizer received reports of liver and kidney failure soon after the drug’s release. However, there are additional reports that Pfizer knew about potential side effects as early as 1998, but waited to change the warning label until they were required by the U.S. Food & Drug Administration to do so in late 2000.

In 2001, the FDA required the company to further update the warning label on Z-Pak about possible Zithromax complications, including abnormal liver function, jaundice, necrosis liver failure and even death.

Zithromax Lawsuits

Pfizer has faced many legal problems due to its manufacturing and marketing of Zithromax.

In June 2012, the FDA warned Pfizer that a promotional brochure for the medicine did not comply with federal rules and regulations. Specifically, the brochure was misleading because it minimized and omitted information about the drug’s risks while making unsubstantiated superiority claims. Additionally, the brochure implied that Z-Pak was suitable to treat conditions that it had not been approved to treat.

Someone who has been injured by this drug may have a valid Zithromax lawsuit. Drug manufacturers have a duty to design a reasonably safe medicine as well as provide adequate warnings. If you or a loved one has liver or kidney damage, then you may not have been adequately warned about Zithromax complications.