GlaxoSmithKline Updates Prescribing Information For Avandia

GlaxoSmithKline (NYSE:
GSK) today announced that the US Food and Drug Administration (FDA) has
approved updated US prescribing information for the thiazolidinediones
(TZD) class of medicines used in the treatment of Type 2 diabetes. This
approval allows GSK to implement changes in the label for Avandia(R)
(rosiglitazone maleate) as previously committed.



The label will contain a boxed warning, which increases the prominence
of an already existing warning for all medicines in the TZD class on the
risk of congestive heart failure (CHF), a well known and well characterized
risk in this class of medicine. The boxed warning also will note that TZDs
are not recommended in patients with symptomatic heart failure, and that
initiation of TZDs in patients with established NYHA Class III or IV heart
failure is contraindicated. The Contraindications have also been updated
regarding initiation of Avandia in patients with NYHA Class III or IV heart
failure.



Information about CHF has been included in the prescribing information
for Avandia since 1999, when the medicine was first approved by the US Food
and Drug Administration. Since 2001, US prescribing information for Avandia
has included a warning for "Cardiac Failure and Other Cardiac Effects" with
a recommendation that use of Avandia be discontinued in patients if their
cardiac status worsened.



The changes related to CHF are being implemented on the labels of all
rosiglitazone-containing products: Avandia, Avandamet(R) (rosiglitazone
maleate and metformin hydrochloride) and Avandaryl(TM) (rosiglitazone
maleate and glimepiride).



More than 4.5 million Americans suffer from CHF, which also is one of
the most common complications of type 2 diabetes. CHF is a condition in
which the heart cannot pump enough blood to the body's other organs, which
can result in fluid retention, or edema. It is also well known that TZDs
can cause some fluid retention, which can lead to or worsen CHF.



The change in CHF labeling is not related to the FDA's review of
additional data on the risk of myocardial ischemic events, which include
heart attack. The FDA held an Advisory Committee meeting on July 30th to
review that data.



Important Safety Information for Avandia(R) (rosiglitazone maleate)



Avandia, along with diet and exercise, helps improve blood sugar
control. It may be taken alone or with other diabetes medicines. For some
people taking Avandia, possible side effects include heart failure or other
heart problems. Further information regarding potential heart-related risks
is currently under review by the FDA. Talk to your doctor as FDA has made
information on potential heart-related risks available to physicians on its
website at fda. Tell your doctor if you have heart problems or heart failure. Avandia can cause your body to keep extra fluid, which
leads to swelling and weight gain. Extra body fluid can make some heart
problems worse or lead to heart failure. If you have swelling or fluid
retention, shortness of breath or trouble breathing, an unusually rapid
increase in weight, or unusual tiredness while taking Avandia, call your
doctor right away. You should not take Avandia if you have liver problems.
Blood tests should be used to check for liver problems before starting and
while taking Avandia. Tell your doctor if you have liver disease, or if you
experience unexplained tiredness, stomach problems, dark urine or yellowing
of skin while taking Avandia. Tell your doctor about all of the medicines
you are taking. If you are taking Avandia with another diabetes medicine
that lowers blood sugar, you may be at increased risk for low blood sugar.
Ask your doctor whether you need to lower the dose of your other diabetes
medicine. Avandia may increase your risk of pregnancy. Talk to your doctor
before taking Avandia if you could become pregnant or if you are pregnant.
If you are nursing, you should not take Avandia. Talk to your doctor for
advice on how to keep your bones healthy. More fractures, usually in the
upper arm, hand, or foot, have been seen in women taking Avandia. Your
doctor should check your eyes regularly. Very rarely, some people have
experienced vision
















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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 gsk.


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