If any of the following Serzone side effects
are present immediately contact your healthcare provider because
it may be a warning sign of Serzone liver failure:
jaundice, witnessed as yellowing of the skin
or eye whites
unusually dark urine
loss of appetite lasting several days or
longer
severe nausea
abdominal pain
rash or hives
seizure
fainting
erection lasting too long
Serzone Warning
Serzone Black Box Warning
On December 7, 2001, the FDA told Serzone manufacturer
Bristol-Myers
Squibb that they must include a Black Box warning
on all Serzone labels informing the antidepressant patients
about the life threatening Serzone liver
damages that can occur. The FDA Black Box
was required to include a Serzone warning letting the
patients know that liver failure that could result had
the potential to end in death or a liver transplant.
Letters were ordered warning doctors of the potential
Serzone liver failures.
On January 9, 2002, the Serzone label was revised when
the FDA and BMS added a Serzone Black Box Warning and
strengthened the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS
sections of the label for Serzone, an antidepressant
drug. Rare cases of liver failure leading to transplant
and/or death in patients have been reported. A new Patient
Package Warning Insert is also provided in the product
packaging.
WARNING
Cases of life-threatening hepatic failure
have been reported in patients treated with
SERZONE. The reported rate in the United States
is about 1 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 warning 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 warning 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 ³ 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.
