Serzone Warnings
Serzone Information
Serzone Warnings
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.
Ordinarily, treatment with Serzone should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
Patients taking Serzone 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. Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels • 3 times the upper limit of NORMAL, while on Serzone should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if Serzone is reintroduced. Accordingly, such patients should not be considered for re-treatment.
