US labeling for Avandia

GlaxoSmithKline PLC
14 November 2007

                     GSK Revises US Labeling for Avandia(R)


November 14, 2007 - London & Philadelphia - 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 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 www.gsk.com.



S M Bicknell
Company Secretary
14th November 2007


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.




Inquiries
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