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.
Put
proven injury lawyers on your side. Contact
Dinkes & Schwitzer at 1-800-933-1212 for
your free legal consultation.
