|
The FDA advised Bristol-Myers Squibb Company
on December 7, 2001 that their anti-depressant drug
Serzone should contain black
box warning labels cautioning drug users of the
side effects of liver damage it has been linked to.
Black box warning labels are the most serious warnings
the FDA ever issues, which warns, "cases of life-threatening
hepatic failure have been reported in patients treated
with Serzone." The life-threatening side effects
of liver failure has been estimated to occur at about
3-4 times the estimated background rate of liver failure.
Figures are estimated to be more conservative than the
actual number of liver complications that have arisen
due to Serzone side effects because of underreporting.
Serzone side effects of liver complications have resulted
in transplant and death. Certain side effects that appear
may indicate if a patient is developing a liver problem,
including jaundice, nausea, anorexia, abdominal pain,
and unusually dark urine. If you notice any of these
adverse side effects and have taken Serzone, immediately
contact your doctor and CONTACT
A SERZONE LAWYER to learn your legal rights.
Other common Serzone side effects include headache,
constipation, dry mouth, drowsiness, insomnia, nausea,
vision problems, agitation, dizziness, fatigue, confusion,
hypotension, rash or hives, seizures, and lightheadedness.
In a study performed on Serzone prior to the marketing
of the drug found 16% of the 3,496 patients taking Serzone
discontinued their use due to side effects. Drowsiness
was the most common of Serzone side effects, experienced
in varying dosages with the drug users.
- allergic to Serzone or Desyrel
- taking terfenadine, astemizole, cisapride, triazolam,
pimozide, carbamazepine
- have liver problems
- taking or have taken within the last 14 days any
of the depression medicines monoamine oxidase inhibitiors
should especially stay away from using Serzone because
of the high risk of developing Serzone side effects.
In addition, anyone who has ever had liver problems,
taking any other medicine, vitamin, herbal remedy, have
heart problems, have had manic episodes, attempted suicide,
have had seizures, or are pregnant or breast feeding
should also be concerned with using, or thinking about
using, Serzone antidepressant pills.
Serious life-threatening Serzone side effects of liver
failure has been reported. There is one case of liver
failure in the U.S. that results in death or a transplant
for every 250,000-300,000 patient-years of Serzone treatment,
a rate of 3-4 times the normal rate of liver failure.
While this increased rate of Serzone liver failure is
substantially higher it still does not demonstrate the
actual rate of Serzone liver failure due to underreporting.
 Cases
of Serzone liver failures resulting in death or transplant
normally ranged from 2 weeks to 6 months on Serzone
therapy. Not all of these Serzone liver failure cases
had prior side effects symptoms indicating the resulting
problems. There is no way of predicting if Serzone liver
failure will occur in a patient, but signs of liver
dysfunction, including jaundice, anorexia, gastrointestinal
complaints, and malaise should be immediately reported
to your healthcare provider should any of these Serzone
side effects surface.
|
