Serzone
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SerzoneŽ (nefazodone HCl) is used to treat depression. It is administered in
tablet form, in dosages of 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg. Serzone
is manufactured by Bristol-Myers Squibb Co. Worldwide sales of Serzone were
$409 million in 2001.
In December, 2001 the US Food and Drug Administration (FDA) told Bristol-Myers
Squibb Co. that it had to include a "black box warning" on the label
for Serzone, indicating that in rare cases people who take Serzone can develop
serious liver problems. Additional information pertaining to this warning can
be found here.
In 2002, there has been at least one class action lawsuit filed in connecton
with Serzone.
- Serzone information from
manufacturer Bristol-Myers Squibb Co.
- Warning
on Serzone Journal of the American Medical Association, Vol. 287, No.
9, March 6, 2002
- Letter,
Full Revised Label, and Patient Package Insert MedWatch, US Food and Drug
Administration, January 9, 2002
- Drugmaker
Must Add Liver-Failure Warning to Label of Antidepressant Serzone WebMD,
December 10, 2001
- Risk
of Severe Liver Injury Associated with Use of the Antidepressant Nefazodone,
Health Canada, July 9, 2001
- March
2001 Safety-Related Drug Labeling Changes (Serzone), MedWatch, US Food
and Drug Administration, March 21, 2001
- January
2001 Safety-Related Drug Labeling Changes (Serzone), MedWatch, US Food
and Drug Administration, January 23, 2001
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