Here's the WLA press release:
Parke-Davis Announces New Label Changes For Its
Type 2 Diabetes Drug, Rezulin
MORRIS PLAINS, N.J., Dec. 1 /PRNewswire/ -- The Parke-Davis division of
the Warner-Lambert Company (NYSE: WLA) 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 (NYSE: GLX), 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.
SOURCE Warner-Lambert Company
-0- 12/01/97
/NOTE TO EDITORS: Warner-Lambert's news releases are available at no
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Full prescribing information is available by calling Parke-Davis Medical
Affairs, 1-800-223-0432./
/CONTACT: Media -- Stephen Mock, 973-540-6696, or Jeff Baum,
973-540-2145, or Leslie Hare, 973-540-4268; or Investors -- George Shields,
973-540-6916, or Jack Howarth, 973-540-4874, all of Warner-Lambert/
(WLA GLX)
CO: Parke-Davis; Warner-Lambert Company; Glaxo Wellcome; Sankyo
ST: New Jersey, North Carolina
IN: MTC
SU:
DG
-- NYM042 --
2261 12/01/97 02:30 EST prnewswire.com |
