Serzone is an anti-depressant that inhibits serotonin reuptake and blocks one type of serotonin receptor. Manufactured by Bristol-Myers Squibb Co., Serzone is prescribed to patients for the treatment of depression causing anxiety.
Unfortunately, patients taking Serzone have reported serious and sometimes fatal liver failure. Estimates from the United States Food and Drug Administration (FDA) report that patients taking Serzone for at least one year have a liver failure rate of one per 250,000 to 300,000. At least 23 reports of liver failure have been cited with at least 16 more having died or undergoing liver transplants.
In December 2001, the FDA announced its requirement that Bristol-Myers Squibb place a black box warning on the drug. This type of warning is designed to alert patients to possible life threatening liver damage that can occur from the use of Serzone. A black box warning is the most stringent warning applied by the FDA.
Following the FDA announcement, Bristol-Myers Squibb Co. issued a manufacturers warning in January 2002 advising health care providers that "cases of life threatening hepatic failure have been reported in patients treated with Serzone." In that same statement, Bristol-Myers Squibb Co. also acknowledged that the "rate [of liver failure] is an underestimate because of under reporting, and the true risk could be greater than this." Bristol-Myers Squibb Co. indicates that it takes 2 weeks to 6 months use of Serzone for liver failure to occur.
If you or a family member has taken Serzone and sustained injury, please contact us.
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