Serzone Information

    SERZONE®, generically known as nefazodone hydrochloride, is
an antidepressant for oral administration in patients battling
depression often with symptoms of anxiety. In 2001, the FDA
issued a revised black box warning on Serzone, a drug taken for
depression that boasts less sexual side effects than other
antidepressants. Reported events of rare but possibly
life-threatening liver failure can occur with use of Serzone. The
language the FDA required on Serzone package labels includes a
warning that "cases of life-threatening hepatic failure have been
reported in patients treated with Serzone."

    In January 2003, Serzone was taken off the market in all
European countries because it has been linked to serious side
effects including 26 deaths from liver damage. Later in November,
the drug was pulled in Canada. On May 19, 2004 Bristol Myers
Squibb announced it would take Serzone off the U.S. market.
Serzone has been widely prescribed with over 4.5 million
prescriptions a year sold in the United States. Sales of Serzone
were $409 million worldwide in 2001.

    Serzone should not normally be prescribed to individuals with
liver disease or with liver inflammation.  Bristol Myers Squibb
advises patients taking Serzone to contact their doctor immediately
if they have any of the following symptoms:

Jaundice (yellowing of the skin or eyes)
Discolored or dark urine
Loss of appetite
Nausea
Abdominal (stomach) pain