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Serzone (nefazodone hydrochloride) is a
prescription drug manufactured by Bristol-Myers Squibb for the
treatment of depression. Unlike other antidepressant drugs, Serzone
was marketed as an antidepressant less likely to decrease sexual
functioning or libido. It was this marketing tool that also lead to
increased sales for the drug. Since its approval by the
U.S. Food
and Drug Administration (FDA) on December 22, 1994, it is estimated
that 8.3 million people worldwide have been prescribed Serzone.
Bristol-Myers reported worldwide Serzone sales of $409 million for
2001.
Warnings regarding Serzone usage
Bristol-Myers Squibb made a labeling change to
Serzone in June 2000, that strengthened its warning about the
possibility of liver necrosis and failure, both of which may lead to
transplantation or death. In December 2001, the FDA instructed
Bristol-Myers to issue a “black box” warning label informing
physicians and patients of the drugs propensity to cause life
threatening liver damage. And, on January 9, 2002, Bristol-Myers
issued a manufacturer’s warning advising patients of Serzone’s
risk of causing life threatening hepatic (liver) failure.
What has happened because of Serzone?
There have been 109 serious injury cases reported
as a result of using Serzone since it appeared on the market in
1994. Of those 109 serious injuries, 23 resulted in liver failure
and 16 resulted in liver transplants. The onset of serious liver
damage usually occurs within 4 months of initiating treatment. Cases
of liver injury have occurred as early as a few weeks after
beginning treatment with Serzone, or after continuous use for up to
1-2 years. In addition to the serious injuries that have occurred as
a result of Serzone usage, there have been 13 deaths attributable to
Serzone.
Possible Side Effects
The possible side effects of Serzone are:
agitation, dizziness, clumsiness or unsteadiness, difficulty
concentrating, memory problems, confusion, severe nausea,
gastroenteritis, abdominal pain, unusually dark urine, difficult or
frequent urination, fainting, skin rash or hives yellowing of the
skin or whites of the eyes (jaundice) or a prolonged loss of weight
or loss of appetite.
On May 19, 2004 Bristol Myers Squibb announced it would stop
selling Serzone in the United States. The drug had previously been
removed from all countries except the U.S.
If you or a family member have suffered serious side effects or a
fatal injury after taking Serzone, you or the family member may be
eligible to file a lawsuit against the manufacturer.
News about Serzone:
Serzone warning by FDA
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