PHILADELPHIA, July 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today welcomed the nearly unanimous recommendation of an U.S. Food and
Drug Administration's (FDA) advisory committee to support Avandia's
(rosiglitazone maleate) continued availability to patients in the US. The
company said it will continue to provide information to the FDA to assist
in the Agency's final decision-making.
On July 30th, the FDA Endocrinologic and Metabolic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee voted
that the data suggests some ischemic risk with Avandia, a treatment for
type 2 diabetes. The committee declined to comment on comparative risk of
Avandia to other oral anti-diabetic medicines. The committee also voted to
keep the medicine available to patients in the US. The FDA will review the
panel's recommendation before making a decision.
"We welcome this decision as positive for patients. This was the first
opportunity for these scientific experts to review the full data behind
Avandia. The committee recognized the debilitating nature of this disease
and the importance of multiple treatment options," said Dr. Ronald Krall,
Chief Medical Officer, GlaxoSmithKline. "Diabetes is a progressive disease
that exacts a terrible toll on its victims, and it is important that
Avandia remain a treatment option for patients."
About GlaxoSmithKline
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. 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 http://www.fda.gov. 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 changes due to swelling in the back of the eye while
taking Avandia.
SOURCE GlaxoSmithKline
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