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
