According to a report published in the Wall
Street Journal, about one person in 250,000 to 300,000 taking
Serzone antidepressant will suffer liver
A number of U.S. psychiatrists became concerned about Serzone
antidepressant and the liver failure problem following the
Canadian government issued 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 antidepressant
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."
Effects of Serzone Antidepressant
and yellow eyes
- Swollen stomach
- Loss of
weight and appetite/
- Pale or black stools/dark urine
loss of con-centration/ confusion/ personality changes
Between 1987 and 1997, the percentage of Americans being treated
for depression more than tripled nationwide, from 0.7 percent to
2.3 percent. The introduction of Serzone antidepressant to the U.S.
market came with great expectations because the antidepressant drug
claimed fewer sexual side effects. There were side
effects that Serzone antidepressant patients did not anticipate,
though, and a pre-marketing study indicated this when 16% of the
patients discontinued the use of the antidepressant because of adverse
side effects. Reports of serious, life-threatening Serzone antidepressant
side effects began to surface involving cases of liver failure leading
to transplantation and/or death.
|Bristol-Myers Squibb Company, the manufacturer
of Serzone antidepressant, is now required by the FDA to include a
Box warning label that advises Serzone patients of the life-threatening
liver failure instances that can occur when using the antidepressant
drug. Approved in 1994, Serzone antidepressant has been used by approximately
8.3 million people worldwide, 7 million in the U.S. alone. Bristol-Myers
has generated about $400 million in annual sales with Serzone antidepressant
If you would like to learn more about your legal rights involving
Serzone antidepressant, please contact
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 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 antidepressant
label change required by the FDA also had to include a warning to
aware patients that liver
failure can result in death or the need for a liver transplant.
Bristol-Myers had to send letters alerting doctors of the potential
Serzone liver failure that could occur when administering the antidepressant
Again, on January 9, 2002, the Serzone antidepressant 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 antidepressant drug. Rare cases
of liver failure leading to transplant and/or death in Serzone antidepressant
drug patients have been reported. A new Patient Package Insert is
also provided in the product packaging.
|If you would like
to learn more about your legal rights involving Serzone antidepressant,
please contact us
The warning that the FDA ordered be added to the label
of Serzone antidepressant included that the time for reported liver
failure cases resulting in death or transplant generally ranged
from two weeks to six months on Serzone antidepressant therapy. Over
109 cases of serious liver damage have been reported as a result of
Serzone antidepressant with at least 23 cases of liver failure that
resulted in 16 liver transplants and/or died.
The liver is the largest organ in the body situated on the right hand
side of the body behind the lower ribs. It performs many complex functions
that are essential to life and health including, making proteins that
enable the blood to clot and allow the body to fight infection, converting
food into substances that allow repair and growth, producing bile
that assists the absorption of fats and certain vitamins, and processing
and removing drugs and other toxic substances.
Our experienced and proven Serzone lawyers
are dedicated to ensuring that every individual that has endured
or is still enduring the serious side
effects of Serzone antidepressant receive the proper compensation
for the injuries suffered. To learn more about your legal rights
and Serzone antidepressant, please contact
A Black Box warning is the strongest type of warning that the FDA
can require in a drug's labeling.
here to read about the FDA's warning on Serzone antidepressant.
Brand name: Serzone
Generic name: nefazodone HCL tablets
How Serzone antidepressant is administered: Serzone antidepressant
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 antidepressant: If you
are still taking Serzone antidepressant drug you are advised to
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.
us to learn more about your legal rights concerning