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The FDA has issued a warning
that cases of life-threatening hepatic failure have been
reported in patients using nefazodone hydrochloride (Serzone),
a treatment for depression. Over 109 cases of serious liver
injuries allegedly associated with Serzone have been reported.
In at least 23 cases, Serzone users experienced liver failure
and 16 underwent a liver transplant and/or died. Bristol-Myers
Squibb, the manufacturer, admits that liver failure rates are
3-4 times greater for Serzone users than non-users. The FDA
estimates that the reported rate of liver failure in Serzone
patients who used the drug for at least one year is about one
case in every 250,000 to 300,000. Pursuant to the FDA's
directives, Bristol-Myers Squibb has now updated its warnings
to both consumers and healthcare practitioners. Patients
taking Serzone should be advised to report signs and symptoms
of liver dysfunction such as jaundice, anorexia, or
gastrointestinal complaints to their physician immediately. If
they develop evidence of hepatocellular injury, such as
increased serum aspartate aminotrasferase or serum alanine at
levels three times or higher than the upper limit of normal,
they should be withdrawn from the drug and should not be
considered for re-treatment.
Serzone was approved by the FDA
for use in the United States for the treatment of depression
in 1994. An anti-depressant in a class of its own in terms of
its structure and composition, Serzone shares some
characteristics with other serotonin uptake inhibitors like
Prozac, Paxil and Zoloft. Serzone generates annual sales of
$400 million for Bristol-Myers.
We are investigating reports
that Bristol-Myers Squibb failed to warn users of a known
danger that the drug could cause life-threatening liver
damage. For further information on the continuing
investigation into the failure of Bristol-Myers Squibb to warn
users of the dangers of Serzone, or to discuss your rights as
a user of the drug (whether or not you have suffered ill
effects), please call us toll free at 888-733-3572.
Serzone FAQsWhat is Serzone?
What is the most important
information I should know about Serzone?
Any other side effects?
What should I do if I believe
I have depression?
Why would Serzone be
prescribed, instead of another antidepressant?
What type of testing can
determine whether or not I have sustained an injury?
Can I receive a
life-threatening injury as a result of the use of Serzone?
Has any legal action been
taken for the deadly and serious Serzone side effects?
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