[tri-med] FYI - Serzone

Received this info from The Birth Defect Research for Children

I am forwarding this article or URL for your information (FYI) as I believe
it may be of interest and is from a reliable source. As always, check the
information with your own doctor or health care professional before starting
or changing any treatments.

Bristol-Myers Squibb Company has sent out this special alert for the
anti-depressant SERZONE.
A new black box warning on the prescribing information for Serzone contains
this information:
____________________________________________________________________________
____
Cases of life-threatening hepatic (liver) failure have been reported in
patients treated with SERZONE.
The reported rate in the United States is about 1 case of liver failure
resulting in death or transplant
per 250,000-300,000 patient-years of SERZONE treatment.  The total
patient-years is a summation
of each patient's duration of exposure expressed in years.  For example, 1
patient-year is equal to
2 patients each treated for 6 months, 3 patients each treated for 4 months,
etc.

Ordinarily, treatment with SERZONE should not be initiated in individuals
with active liver disease
or with elevated baseline serum transaminases.  There is no evidence that
pre-existing liver disease
increases the likelihood of developing liver failure, however baseline
abnormalities can complicate
patient monitoring.

Patients should be advised to be alert for signs and symptoms of liver
dysfunction (jaundice, anorexia
(loss of appetite), gastrointestinal complaints, malaise, etc.) and to
report them to their doctor immediately
if they occur.

SERZONE should be discontinued if clinical signs or symptoms suggest liver
failure.  Patients who develop
evidence of heaptocellular injury such as increased serum AST or serum ALT
levels >  3 times the upper
limit of NORMAL, while on SERZONE should be withdrawn from the drug.  These
patients should be
presumed to be at increased  risk for liver injury if SERZONE is
reintroduced.  Accordingly, such patients
should not considered for re-treatment.
____________________________________________________________________________
____________
Healthcare professionals are strongly encouraged to report any serious
adverse reactions that occur with
the use of SERZONE to 1-800-321-1335 or to the FDA's MedWatch program at
1-800-FDA-1088 or
via the MedWatch website at www.FDA.gov/medwatch.


                  Building ___ooOOoo__ Rainbows
                       www.trisomyonline.org
                  Families Helping Families On-line

Other related posts: