FDA tells Bristol-Myers to add black box Serzone warning--December, 2001
The US Food and Drug Administration has told drug maker Bristol-Myers Squibb Co. that it must include a black-box warning on its label for the antidepressant Serzone (nefazodone) telling patients that life-threatening liver damage can occur when using the drug.
The FDA estimated the reported rate in this country is about one case of liver failure for every 250,000 to 300,000 patients using the drug for one year.
The language the FDA will require on Serzone package labels will include warnings that "cases of life-threatening hepatic failure have been reported in patients treated with Serzone".
The black-box designation refers to a black outline surrounding a section of the label and of the Physicians' Desk Reference, reserved for only the most serious side effects. When doctors see this warning they will not use the drug unless it is a last resort for life threatening cases.
Serzone does about $400 million in annual sales. A black-box warning will seriously decrease the sales of Serzone.
Below is the black box warning.
WARNING
Cases of fife-threatening hepatic failure have been reported in patients treated with SERZONE.
The reported rate in the United States is about I 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. (See WARNINGS.)
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 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 (see PRECAUTIONS: Information for Patients). 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3 times the upper limit of NORMAL, while on SERZONE should be withdrawn from the drug.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.
If you or someone you know is taking Serzone and have experienced liver damage you may be entitled to compensation. Contact us for legal consultation
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