Serzone Liver Damage
Serzone, an anti-depressant has been linked to liver failure. The manufacturer stated in January 2002 the rate of liver failure associated with Serzone use is about 3-4 times than greater than non-users.
Serzone's manufaturer Bristol-Myers Squibb Co. issued this warning telling health care providers that "cases of life-threatening hepatic failure have been reported in patients treated with SERZONE." The warning also related the company believes that numerous patients have experienced or will suffer liver failure.
More on Serzone Side Effects
The New Warnings:
The FDA told the company to add a Black Box Warning and strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS sections of the label for Serzone. A Black Box warning tells prescribing physcians that the side effects of a drug are very serious. Most physcians will not prescribe a drug with such a warning unless the benefits clearly outweigh the risks.The new language required by the FDA on Serzone packaging labels will includes warnings that "cases of life-threatening hepatic failure have been reported in patients treated with Serzone."
Canadian Government ActionIn Canada the government required the company to send a letter in June 2001 to doctors telling them of reports that there had been 109 serious hepatic (liver) events world-wide, including 23 cases of liver failure and 16 cases of liver failure and death.
The letter is reproduced here:
Bristol-Myers Squibb Canada Inc. Linson Pharama Inc.
Important Safety Information
June 20, 2001Important Safety Information on NFFAZODONE HCL:
Severe and Serious Hepatic EventsDear Health Care Professional,
Bristol-Myers Squibb Canada Inc. and Linson Pharma Inc. would like to advise you of very rare reports of severe liver injury temporally associated with the use of the antidepressant nefazodone HCI sold by Bristol-Myers Squibb under the trade name Serzone-5HT2 and by Linson under the trade name LinNefazodone. Nefazodone is indicated for the symptomatic relief of depressive illness.
Nefazodone has been evaluated in more than 8000 clinical trial subjects and has been used by approximately 8.3 million patients worldwide since its market introduction in 1994. Worldwide post marketing safety experience has resulted in the identification of 109 serious (requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is life-threatening or results in death) hepatic adverse events in temporal association with nefazodone. These include 23 cases of liver failure worldwide of which 16 led to transplantation and/or death. Among an estimated 650,000 patients treated with nefazodone in Canada, four cases of liver failure have been reported of which two required liver transplantation. Nefazodone has also been temporally associated with hepatic adverse events such as jaundice, hepatitis and hepatocellular necrosis in patients receiving therapeutic doses. Reporting rates determined on the basis of spontaneously reported post-marketing adverse events are generally presumed to underestimate the risks associated with drug treatments.
Although some of the reported cases of severe hepatic injury have confounding factors such as concomitant medications, alcohol, or the presence of underlying disease, a possible causal role for nefazodone cannot be excluded. Among the cases of liver failure, two-thirds had the onset of symptoms within the first 4 months of initiation of treatment. Cases of liver injury have occurred as early as a few weeks after initiation of therapy or after continuous use for up to 1-2 years.
Clinical manifestations of severe hepatic injury in patients have included the following: anorexia, fatigue, asthenia, malaise, abdominal pain, nausea, vomiting, discolored stools, dark urine, prolonged coagulation, weight loss, jaundice, ascites, confusion, asterixis, encephalopathy, and hepatic coma. Laboratory evidence of hepatotoxicity has included increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, - -glutamyl transpeptidase (GGT), and bilirubin, as well as increased prothrombin times.
Prior to prescribing nefazodone, physicians should counsel their patients to be alert to the premonitory signs and symptoms listed above and to seek emergency medical attention if these develop. The appearance of signs and symptoms of hepatotoxicity, or the development of abnormal aminotransferase and/or bilirubin levels while on treatment is an indication for immediate termination of nefazodone treatment and close monitoring of the patient. In most cases, discontinuation of nefazodone has been associated with recovery, while in rare cases hepatic dysfunction has progressed to liver failure and, even less frequently, death, in spite of discontinuation of the drug. The occurrence of liver injury can be fatal even if properly recognized and managed.
Health care professionals are also reminded that nefazodone is a potent inhibitor of the hepatic drug metabolizing enzyme, CYP3A4, and has the potential to decrease the metabolism of many concomitantly administered drugs and other xenobiotics, potentially increasing the toxicity of these agents.
Bristol-Myers Squibb and Linson Pharma continue to work actively with Health Canada to monitor adverse event reports and to ensure that up-to-date information regarding the use of nefazodone is available. Revisions to the existing product monographs with respect to serious liver injury have been requested by Health Canada. Copies of the current product monographs are available on request from Bristol-Myers Squibb (Serzone-5HT2) or Linson (LinNefazodone). Health Care Professionals will be advised of the revisions as soon as possible.
Your professional commitment in this regard has an important role in protecting the well-being of your patients by contributing to early signal detection and informed drug use.
Yours sincerely,
original signed by
Vicky Esposito
Senior Director
Regulatory Affairs and Quality Assurance
Bristol-Myers Squibb Canada Inc.Laura King
Associate Director
Regulatory Affairs
Linson Pharma Inc.
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