Serzone®

Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE®.

The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 - 300,000 patient-years of SERZONE® treatment. The total patient-years is a summation of each patient's duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc.

Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.

SERZONE® should be discontinued if clinical signs or symptoms suggest liver failure.

Source: fda.gov

On May 19, 2004, Bristol-Meyers Squibb, the manufacturer of Serzone, announced plans to remove the drug from the U.S. market. According to the company, production of Serzone is being halted for "commercial reasons."

If you or a loved one has been harmed by Serzone®, you may want to contact a Serzone® attorney for more information.