SERZONE WARNING
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According to a report published in the Wall
Street Journal, about one person in 250,000 to 300,000 taking
Serzone will suffer liver failure.
A number of U.S. psychiatrists became concerned about the
Serzone liver failure problem following the Canadian government
issued Serzone warning on June 20, 2001.
A company spokeswoman at Bristol-Myers was asked why Serzone
warnings were sent to Canada but not to American physicians
warning of the possible fatal liver damage Serzone can cause.
The spokeswoman, Tracy Fury, responded that, "We
didn't' think it was necessary in the U.S. because what happened
in Canada was specific to Canada."
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Serzone
Side Effects Warnings
- Skin
jaundice
and yellow eyes
- Bruising
- Swollen stomach
- Itching
- Loss of
weight and appetite/
weak
muscles
- Pale or black stools/dark urine
- Tiredness/
loss of con-centration/ confusion/ personality changes
- Problems
with
sleeping
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Bristol-Myers Squibb was told by the FDA on December 7, 2001 to
include a Black Box warning on all Serzone antidepressant labels
to inform patients of the serious risk of life threatening Serzone
liver damages that had been surfacing. A Black Box warning is
the strongest type of warning that the FDA can require in a drug's
labeling. The Serzone label warning change required by the FDA also
had to include a warning that liver failure can result in death
or the need for a liver transplant. Bristol-Myers had to send letters
warning doctors of the potential Serzone liver failure that could
occur when administering the antidepressant medication.
Again, on January 9, 2002, the Serzone warning label was revised
when the FDA and BMS added a Black Box Warning and strengthened
the WARNINGS, CONTRAINDICATIONS, and PRECAUTIONS
sections of the label for Serzone. Rare cases of Serzone liver failure
leading to transplant and/or death in patients have been reported.
A new Patient Package Insert is also provided in the product packaging.
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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 levels³ 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.
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www.fda.gov
View
the Full Revised Serzone Label
View
the Serzone Patient Packet Insert
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:Quick
Serzone Warning Guide:
Brand name: Serzone
Generic name: nefazodone HCL tablets
How Serzone is administered: Serzone comes in the form
of tablets and are taken orally. They come in five dosages: 50
mg, 100 mg, 150 mg, 200 mg, and 250 mg.
What to do if still taking Serzone: If you are still taking
Serzone antidepressant drug you are advised to check for warning
signs and immediately talk to your doctor about the best options
to discontinue the use of the drug that has been linked to dangerous
cases of Serzone liver damage.
Contact
us to learn about Serzone warning signs and symptoms
and your legal rights.
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