Warner-Lamber's statement:
WARNER-LAMBERT CO. ISSUED THE FOLLOWING STATEMENT TODAY IN RESPO
PR Wire
December 7, 1998, 5:41 p.m. ET
se to Recent
Media Reports Regarding Rezulin (Troglitazone) Its Therapy for Type 2 Diabetes
MORRIS PLAINS, N.J., Dec. 7 /PRNewswire/ -- Warner-Lambert Company today
stated that it is disappointed with the mischaracterization of its actions and
intentions regarding the development and marketing of Rezulin (troglitazone),
its therapy for type 2 diabetes. The Company has always been forthcoming with
information regarding the safety and efficacy of this therapy with both the
U.S. Food and Drug Administration and health care professionals. Furthermore,
Warner-Lambert is particularly disturbed about recent media coverage of the
drug that seems to focus primarily on risks but largely ignores the
significant patient benefits that the medication provides.
Therapies such as Rezulin bring tremendous benefit to hundreds of
thousands of patients every day. However, like other anti-diabetic agents,
and most other prescription pharmaceutical products, Rezulin may be associated
with certain side effects. And while there may be rare adverse hepatic events
associated with Rezulin, these events must be viewed in the context of the
hundreds of thousands of patients that are currently benefiting from the drug.
There are more than 15 million people with type 2 diabetes. Many of these
people go on to experience the devastating effects of this disease, such as
blindness, amputation, kidney failure and ultimately death. It is in that
context that the benefit to risk ratio must be weighed and why the Company
maintains, and the FDA continues to support the view that the benefits of
Rezulin outweigh its risks.
Recent media reports have stated that there have been a total of 33 deaths
in the U.S. and Japan, primarily involving patients who may not have been
monitored as recommended in the labeling. Additionally, each of these events
occurred with patients that started therapy prior to the most recent changes
in labeling. While Warner-Lambert cannot exclude the possibility of future
serious adverse events, the Company believes that with proper monitoring,
health care professionals can keep these rare but serious events to an
absolute minimum.
Since the first label revisions in 1997 that recommended periodic
monitoring of liver function, the rate of serious liver-related adverse events
has fallen substantially. To date, more than 1.4 million patients in the U.S.
have begun Rezulin therapy.
Warner-Lambert has and will continue to thoroughly monitor adverse events
through its extensive safety surveillance monitoring system and will continue
to quickly communicate this information to the U.S. Food and Drug
Administration. The Company will also continue to provide health care
professionals with accurate and up to date information about how to use this
medication.
Rezulin brings significant benefits to patients in terms of blood sugar
control, enabling many patients for the first time, to reach their American
Diabetes Association goals. It is also the first therapy to allow patients
taking insulin to reduce or in some cases, eliminate their need for daily
insulin injections. With a progressive disease such as type 2 diabetes,
ongoing management is fundamental to the long-term health of the patient. The
importance of Rezulin in helping patients achieve control is evident in the
growing numbers of patients who have taken Rezulin successfully.
For more than 130 years, Warner-Lambert has been conducting pharmaceutical
research to bring valued medications to the millions of patients who need
them. Today Warner-Lambert's more than 40,000 employees many of whom rely on
these treatments, help bring hundreds of medicines to tens of millions around
the world.
As a company, Warner-Lambert has worked closely with healthcare providers
and patients to provide safe and reliable products. The Company remains
committed to this ongoing endeavor.
Rezulin may be used concomitantly with a sulfonylurea or insulin to
improve glycemic control. Rezulin, as monotherapy, is indicated as an adjunct
to diet and exercise to lower blood glucose in patients with type 2 diabetes.
Rezulin should not be used as monotherapy in patients previously well
controlled on sulfonylurea therapy. For patients inadequately controlled with
a sulfonylurea alone, Rezulin should be added to, not substituted for, the
sulfonylurea.
Management of type 2 diabetes should also include diet control, weight
loss, and exercise. Rezulin should not be used in type 1 diabetes or for the
treatment of diabetic ketoacidosis.
In clinical studies, Rezulin was well tolerated. The incidence of
withdrawals during clinical trials was similar for patients treated with
placebo or Rezulin (4 percent). The most common adverse events included
infection (22 percent placebo vs. 18 percent Rezulin), headache (11 percent
placebo vs. 11 percent Rezulin), and pain (14 percent placebo vs. 10 percent
Rezulin). In rare cases, Rezulin has been associated with serious liver
problems which are usually reversible. In very rare cases, these have
resulted in liver failure leading to death or liver transplant. Serious liver
events have occurred after both short and long term troglitazone treatment.
Therefore, Rezulin patients should be monitored regularly for liver function.
Serum transaminase levels should be checked at the start of therapy, monthly
for the first eight months of therapy, every two months for the remainder of
the first year of Rezulin therapy, and periodically thereafter. In
premenopausal anovulatory patients with insulin resistance, Rezulin treatment
may result in resumption of ovulation. These patients may be at risk for
pregnancy. Rezulin should not be used during pregnancy unless the potential
benefit justifies the potential risk to the fetus.
Rezulin has not been tested in patients with New York Heart Association
(NYHA) Class III and IV cardiac status; therefore, Rezulin is not indicated
unless the expected benefit is believed to outweigh the potential risk to
these patients.
SOURCE Warner-Lambert Co.
-0- 12/07/98
/CONTACT: Media - Stephen Mock, 973-540-6696, or Carol Goodrich,
973-540-3620, or Investor - George Shields, 973-540-6916, or Jack Howarth,
973-540-4874, all of Warner-Lambert Co./
/Company News On-Call: prnewswire.com or fax,
800-758-5804, ext. 958887/
(WLA) |
