On January 8th, 2003, Serzone was removed from the
market in all European countries because it has been linked to
26 deaths from liver damage. This follows a black box warning
issued by the FDA in 2001.
In December, 2001 The Food and Drug Administration
notified Bristol-Myers Squibb Co. that it must include a
so-called black-box warning on its label for the
antidepressant Serzone advising patients about cases of
life-threatening liver (hepatic) failure that have been
reported in patients treated with the drug. A black-box
warning label is the most serious warning issued by the
Federal Food and Drug Administration.
Serzone should not be prescribed to individuals with
active liver disease or with elevated baseline serum
transaminases. Patients taking Serzone should be advised to be
alert for signs and symptoms of liver dysfunction such as:
jaundice, anorexia, gastrointestinal complaints, and malaise.
If any of these signs exist you should report them to their
The reported rate in the United States of liver failure
resulting in death or transplant is one patient per 250,000 –
300,000 patient-years of SERZONE treatment. This represents a
rate of about 3-4 times the estimated background rate of liver
failure. However this rate is an underestimate because of
under reporting, and the true risk could be considerably
greater than this. The FDA has stated that there is no way to
predict who is likely to develop liver failure.