Zithromax, also known as Z-Pak, is a popular antibiotic manufactured by Pfizer for the treatment of mild to moderate infection. Zithromax has been linked to an increased risk of liver damage, elevated liver enzymes, jaundice and death.

First approved by the FDA in 1992 to treat certain respiratory and skin infections, 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 drug, including liver damage resulting in the need for liver transplant surgery and liver damage resulting in death.

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

Zithromax and Liver Failure

Zithromax is filtered out of the body by the liver. The risk of Zithromax liver damage is increased because the medicine is particularly powerful.

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 the drug. Hepatotoxicity (toxic liver disease) and hepatitis have been reported in patients taking Zithromax, occasionally resulting in death.

Symptoms of Zithromax liver damage include:

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

Zithromax FDA Warning

Pfizer received reports of liver failure soon after the drug’s release but there are additional reports that Pfizer knew about potential Zithromax side effects on the liver 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 jaundice as well as 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 damage, then you may not have been adequately warned about Zithromax complications.