Pfizer is facing a lawsuit alleging that its popular antibiotic Zithromax is to blame for a case of liver failure, which resulted in the need for a liver transplant. The lawsuit was filed in March 2016 on behalf of a 23-year-old man who alleges he took Zithromax for three days when he was 16 years old before suffering liver damage.
The lawsuit alleges his liver damage and subsequent need for a liver transplant was the result of taking Zithromax, known by its generic name as azithromycin. He alleges that Pfizer has received reports of liver failure soon after the drug was approved in 1994, but failed to warn the public until 2000. The U.S. Food and Drug Administration (FDA) ordered Pfizer to update the Zithromax label in 2001 to warn about the risk of liver damage.
In 2011, the label was updated to state “Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.”
Signs of liver failure include:
• abdominal pain
• nausea and vomiting
• clay-colored stools
• severe fatigue
• jaundice (yellowish color in the skin or eyes)
• dark urine
• abnormal or elevated liver enzymes
Zithromax is used to treat mild to moderate bacterial infections such as acquired pneumonia, acute exacerbations of chronic bronchitis, sinusitis, pelvic inflammatory disease, urethritis and other conditions caused by susceptible bacteria. It is available as a tablet, liquid and an extended-release liquid.
A liver transplant is sometimes required when liver damage occurs rapidly, or when it goes untreated. The lawsuit alleges that Pfizer was aware of liver toxicity risks but failed to update the label at the time the plaintiff took Zithromax.
In 2009, Pfizer agreed to pay $2.3 billion to settle criminal and civil allegations involving Zithromax and 12 other drugs. The government alleged that Pfizer engaged in off-label marketing, where a drug is marketed for an unapproved use, and paying kickbacks to doctors. Pfizer paid a $1.2 billion criminal fine, $1 billion in civil penalties and $100 million in criminal forfeiture.