A class action has been brought against
Bristol-Myers Squibb Company, Inc., the maker of the
prescription antidepressant Serzone (nefazodone
hydrochloride), to recover for liver damage and other injuries
suffered by patients taking this drug. The action alleges that
the manufacturer either knew or should have known that Serzone
is associated with liver failure and other life-threatening
complications. Accordingly, the action asserts that the drug
is unreasonably dangerous. The action asks the court to order
the manufacturer to provide medical monitoring to patients who
have taken Serzone to watch them for signs of liver damage and
other complications.
According to the Los Angeles Times, eighteen cases of liver
failure involving Serzone patients were reported to the
federal Food and Drug Administration (FDA) from 1996 to June
2000. Several cases have been described in the medical
literature. The FDA approved Serzone in December, 1994.
In an article titled "Nefazodone-induced liver failure:
report of three cases," a group of Cincinnati, Ohio physicians
reported that three women, 16 to 57 years old, who were taking
Serzone developed severe liver damage. Two of the women needed
a liver transplant; the third was listed for transplantation
but subsequently improved. The women had been taking Serzone
for 14 to 28 weeks before the onset of symptoms. The
physicians concluded that Serzone is unpredictable in terms of
when it can cause liver damage.
One of these three patients, Alissa Robinson, who was only
15 when Serzone was first prescribed for her, has been
profiled in an investigative report in the Los Angeles Times.
She almost died, had a liver transplant, and now faces a
lifetime of uncertain health and worry over how she will pay
for her medical care. The newspaper's story reported that,
when Serzone was approved, the Food and Drug Administration
knew that it had not been shown to be safe for use in children
and adolescents. While the manufacturer promised to research
the effect of Serzone use on younger patients and to report
the results to the FDA, no such results have been provided.
The company now says it hopes to report results to the FDA "in
the early part of 2002."
In a case report titled "Reversible Nefazodone-induced
liver failure," physicians at the Medical University of South
Carolina described a 46-year-old woman who came to the medical
clinic with a 2-month history of fatigue. A liver biopsy
revealed "ballooning degeneration and necrosis of hepatocytes
in zone III, as well as extensive mixed inflammatory cell
infiltrates, with occasional eosinophils." Four months after
stopping Serzone, the woman's liver function tests had
returned to normal. The physicians concluded that the woman's
"severe hepatocellular jaundice" was attributable to the
Serzone.
In clinical trials before Serzone was approved, several
other side-effects were noticed: dry mouth (25%), drowsiness
(25%), nausea (22%), dizziness (17%), constipation (14%),
weakness (11%), lightheadedness (10%), blurred vision (9%),
confusion (7%) and abnormal vision (7%). [The percentages
represent the frequency of the occurrence of a particular side
effect in the trials.] Serzone also may cause a mood swing
called hypomania. Symptoms of hypomania include euphoria,
racing thoughts, pressured speech, and excessive
energy.
