FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T97-55                           Marian Segal:      301-827-6242
November 3, 1997                 
                                 Consumer Hotline:  800-532-4440


                     REZULIN LABELING CHANGES
     The manufacturer of the diabetes drug Rezulin (troglitazone)
is changing prescribing information for the product and adding
new warning information to the labeling, in response to reports
of liver injury associated with use of the drug.
     Rezulin is used in combination with insulin or sulfonylurea
in patients with type II diabetes (adult-onset diabetes mellitus)
whose blood glucose levels are not adequately controlled by these
other therapies alone.
     About 500,000 patients in the United States have been
treated with Rezulin since it came on the market in January 1997;
of those, approximately 85,000 have been taking the drug for six
months or more. As of October 21, 1997, 35 post-marketing reports
of liver injury of various degrees have been received. These
reports ranged from mildly elevated blood levels of the liver
transaminase enzymes to liver failure leading to one liver
transplant and one death. Whether the drug was solely responsible
for all of these reports of liver injury is as yet unknown, due
to confounding medical factors in some of the reported cases. 
     Based on these reports, FDA and the manufacturer are 
recommending that serum transaminase levels in patients be
checked routinely within the first one to two months of Rezulin
therapy, every three months thereafter during the first year of
treatment, and periodically thereafter.  In addition, liver
function tests should be performed on any patient on Rezulin  who
develops symptoms of liver dysfunction, such as nausea, vomiting,
abdominal pain, fatigue, loss of appetite, or dark urine.
Patients on Rezulin who develop jaundice or whose laboratory
results indicate liver injury should stop taking the drug.
     Based on clinical trials, approximately two percent of
patients on Rezulin can be expected to have to stop taking the
drug because of elevated liver enzymes. Few, if any, of these
patients will go on to develop permanent liver damage if the drug
is stopped.
      The new prescribing information and labeling warning are
designed to give health care providers and patients the latest
available information about possible risks associated with
Rezulin and recommendations for safer use of the drug.
     Health care providers are urged to report any Rezulin
-related adverse events, especially those suggestive of possible 
liver injury, to the manufacturer, Parke Davis, at 1-800-223-0432, 
or FDA MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-0178 or
(mail) FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
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