LONDON and PHILADELPHIA, Nov. 14 /PRNewswire-FirstCall/ --
GlaxoSmithKline announced today that it is implementing changes to the US
product label for Avandia(R) (rosiglitazone maleate), based on an extensive
and thorough review by the FDA of myocardial ischemia data on Avandia, the
most widely studied oral anti-diabetic medicine available.
The existing boxed warning has been revised to add the FDA's conclusion
that, while an FDA meta-analysis of short-term studies -- mostly against
placebo -- showed an association between Avandia and an increase in
myocardial ischemic events, that risk was not confirmed or excluded in
three long-term clinical trials comparing Avandia against both placebo and
other oral anti- diabetes medicines. The box will state that the available
data on the risk of myocardial ischemia are inconclusive.
The FDA has also concluded there is insufficient information available
to determine whether any oral anti-diabetic medicine reduces cardiovascular
risk. The FDA has directed that the sentence -- "There have been no
clinical studies establishing conclusive evidence of macrovascular risk
reduction with Avandia or any other oral antidiabetic drugs" -- will be
added as a warning on the labels of all oral anti-diabetic medicines.
The Avandia label also has been updated to add that Avandia is not
recommended -- though not contraindicated -- for use with patients who are
taking insulin or nitrates. The label summarizes the data on myocardial
ischemia to help doctors continue to evaluate which patients could benefit
from taking Avandia, and those for whom alternative treatment should be
considered.
The changes are now included in labeling for Avandia, and will be
incorporated into future revised labeling for all approved
rosiglitazone-containing products, including Avandamet (rosiglitazone
maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate
and glimepiride). GSK is also preparing a Medication Guide to help educate
patients about potential benefits and risks and to provide other
information on Avandia.
"Avandia remains a safe and effective medicine for most patients with
type 2 diabetes when used appropriately," said Dr. Ronald Krall, GSK Chief
Medical Officer. "Given the severity of this disease and the importance of
Avandia in helping patients manage their diabetes, we will continue to work
with the FDA to conduct more studies about the safety and benefits of our
medicine."
As previously stated by GSK, two long-term trials in diabetic patients
comparing Avandia to other oral anti-diabetic medicines show no increased
risk for cardiovascular events compared to other commonly used medications,
other than the well-known risk of congestive heart failure with TZDs. One
trial -- ADOPT -- shows no increased myocardial ischemic risk compared to
metformin or sulfonylurea. The interim results of a second long-term trial
-- RECORD -- also show no increased risk of major cardiovascular events
(death, heart attack and stroke) between Avandia and other medications;
however, firm conclusions cannot be drawn because the trial has not yet
been completed. The updated label includes data from ADOPT and RECORD plus
a third long-term trial in pre-diabetic patients (DREAM) which show there
was no increased risk of
Avandia over comparators with regard to myocardial infarction,
mortality, or other non-heart failure cardiovascular events.
GSK believes data from ongoing and future clinical trials will provide
additional scientific support for both the benefit and safety of Avandia.
GSK has agreed to work with the FDA to plan and carry out a clinical trial
to further investigate the cardiovascular effects of Avandia.
Avandia has been prescribed to more than seven million people over the
last seven years to help them control their blood sugar levels.
Importantly, Avandia has been shown to control blood sugar for longer than
the most commonly used oral anti-diabetic medicines -- up to five years.
Long-term glycemic control is important to help prevent the serious
complications of diabetes, especially microvascular complications leading
to blindness, amputation and kidney failure. Avandia is an important
treatment option for physicians, since two-thirds of diabetic patients
suffer with uncontrolled disease and many require two or three medicines to
maintain their blood sugar.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar
control in patients with type 2 diabetes. Avandia can cause or worsen heart
failure. If you have severe heart failure (very poor pumping ability of the
heart), you cannot be started on Avandia. Avandia is also not recommended
if you have heart failure with symptoms (such as shortness of breath or
swelling) even if these symptoms are not severe. Avandia may increase your
risk of other heart problems that occur when there is reduced blood flow to
the heart, such as chest pain (angina) or heart attack (myocardial
infarction). This risk appeared higher in patients taking medicines called
nitrates or insulin. Taking Avandia with insulin or with nitrates is not
recommended. If you have chest pain or a feeling of chest pressure, you
should seek immediate medical attention, regardless of what diabetes
medicines you are taking.
If you take Avandia, tell your doctor right away if you:
-- Have swollen legs or ankles, a rapid increase in weight or difficulty
breathing, or unusual tiredness
-- Experience changes in vision
-- Become pregnant
Review your medical history and tell your doctor if you:
-- Have heart failure or other heart problems
-- Have liver problems or liver disease
-- Are pregnant or are nursing
Women taking Avandia should know that Avandia may increase the risk of
pregnancy. More fractures have been observed in women taking Avandia.
For more information about Avandia, please see Patient Information. For
further information on Avandia, please see full Prescribing Information.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities
Litigation Reform Act of 1995, the company cautions investors that any
forward-looking statements or projections made by the company, including
those made in this Announcement, are subject to risks and uncertainties
that may cause actual results to differ materially from those projected.
Factors that may affect the company's operations are described under 'Risk
Factors' in the 'Business Review' in the company's Annual Report 2006.
SOURCE GlaxoSmithKline
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