PARKE-DAVIS ANNOUNCES NEW LABEL CHANGES FOR ITS
TYPE 2 DIABETES DRUG, REZULIN
MORRIS PLAINS, N.J., December 1, 1997 -- The Parke-Davis division of
the Warner-Lambert Company announced today new label changes for
Rezulin (troglitazone), its drug for type 2 diabetes. These changes,
which will be finalized within the week, will prominently recommend
physicians monitor patients more frequently for signs of liver
dysfunction. These changes are being made to further reduce, to an
absolute minimum, the risk for very rare but potentially serious
adverse liver events.
On November 3, 1997, Parke-Davis initiated a change in the prescribing
information for Rezulin (troglitazone). This came in response to rare
reports of liver dysfunction potentially associated with the drug. At
that time, health care professionals were informed about a new
monitoring schedule for patients taking Rezulin and were provided
additional information that would help to detect symptoms of adverse
liver elevations.
As expected, heightened awareness following the November 3 label change
has generated some additional reports of hepatic dysfunction. However,
reports-to-date do not indicate a greater incidence of hepatic events
than what was seen in the clinical trials which resulted in priority
review and approval by the FDA. Most of these reports involve mild
elevations of liver enzymes, unassociated with symptoms, and usually
disappear.
These new label changes will recommend that physicians evaluate liver
enzymes prior to initiating therapy, monthly for the first six months
of treatment, bi-monthly for the next six months and periodically
thereafter. Previously, the company recommended physicians monitor
liver enzymes during the first two months of treatment, every three
months for the first year, and then periodically thereafter. The exact
wording of the labeling changes will be finalized between the FDA and
Parke-Davis and promptly communicated to health care professionals in
the next week. In the interim, the company is alerting 400,000 health
care providers to the upcoming changes.
Parke-Davis began marketing Rezulin in March, 1997 and has extensive
post-marketing experience with the drug. Approximately 600,000
patients have taken the therapy in the U.S. and an additional 200,000
in Japan. During these eight months, patients have experienced
significant benefits from Rezulin.
A large number of patients with this debilitating and deadly disease
can now, with the help of Rezulin, reach their American Diabetes
Association goals for blood glucose management. For many, Rezulin has
even enabled them to reduce or eliminate their daily use of insulin.
Based on these profound benefits, combined with safety data from the
post-marketing adverse event reporting in the U.S., Parke-Davis
reaffirmed its confidence in and commitment to this breakthrough
therapy.
In a similar action, Sankyo, the innovator and manufacturer of the drug
for Asian markets, today also upheld its commitment to Rezulin.
Following review of the worldwide safety data, the Japanese Ministry of
Health and Welfare and Sankyo are announcing today that it will modify
the prescribing information for Noscal (troglitazone) to include a
schedule of liver function monitoring similar to the U.S. labeling.
However, Glaxo Wellcome, the manufacturer of Romozin in the U.K., has
decided to temporarily suspend marketing of the drug pending its review
of the safety data. Glaxo Wellcome recently received approval of
Romozin and has experience with approximately 5,000 patients. The FDA
and Parke-Davis have thoroughly reviewed the worldwide database and
continue to find a favorable benefit to risk relationship for Rezulin.
Glaxo Wellcome's action has no impact on the availability of Rezulin
(troglitazone) in the U.S. Rezulin is a highly effective therapy which
Parke-Davis and the FDA, believe should continue to be made available
to the millions of Americans who suffer with type 2 diabetes, and that
the benefits of Rezulin outweigh the potential for serious, but rare,
adverse liver events.
It is important to note, that all therapies currently available to
treat type 2 diabetes have potentially serious side effects. These
label changes will provide health care providers and patients with the
latest available information about the potential risks associated with
Rezulin, while continuing to make this breakthrough therapy available
to patients in need.
Type 2 diabetes is a serious and life threatening disease that affects
six percent of the U.S. population and accounts for over 15 percent of
health care costs in this country. It is a leading cause of coronary
heart disease, blindness, kidney failure, and amputation.
Parke-Davis is a leader in diabetes research and will continue to work
closely with the National Institutes of Health, the American Diabetes
Association, the Endocrine Society and the American Association of
Diabetes Educators. We are committed to an extensive clinical
investigation program for new indications for Rezulin, which includes
studies in impaired glucose tolerance, post-gestational diabetes and a
disease affecting women known as polycystic ovarian syndrome.
Our overriding commitment has always been, as it is today, to provide
patients with safe and effective pharmaceutical products. Rezulin is a
modern breakthrough that is safe and effective as prescribed by the
physician and one that is well-tolerated by its vast majority of
patients.
The company does not believe that the labeling changes will appreciably
diminish the population of patients eligible for this important
medication, but will be assessing, over the next few months, what
effect, if any, the labeling changes may have on expected sales and
earnings for 1998. As previously communicated, Warner-Lambert is
committed to providing superior earnings growth through the rest of
this decade.
Warner-Lambert is a worldwide company devoted to discovering,
developing, manufacturing, and marketing quality pharmaceutical,
consumer health care and confectionery products. It employs
approximately 40,000 people.
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Contact: Stephen Mock, 973-540-6696; Jeff Baum, 973-540-2145 or Leslie
Hare, 973-540-4268 (media); and George Shields, 973-540-6916 or Jack
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