GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
PHILADELPHIA, Oct. 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today issued the following response to a petition filed by Public
Citizen to the U.S. Food and Drug Administration (FDA) on AVANDIA(R)
(rosiglitazone maleate), a highly effective therapy for treating type 2
diabetes when used in the appropriate patient population.
The safety of patients using our medicine is very important to us. On a
continual basis, an external Hepatic Safety Board reviews any adverse event
report received by GSK of liver failure, liver-related deaths and liver
transplants for possible relationship to AVANDIA. As recently as July 2008,
this panel of experts continued to endorse a favorable hepatic safety
profile for AVANDIA.
Patients being treated with AVANDIA or other medicines to control blood
sugar levels should remain on therapy, unless their doctor advises a
different course of action.
AVANDIA has been shown to be a safe and highly effective treatment for
type 2 diabetes for the appropriate patient. GSK strongly supports the
safety and efficacy of AVANDIA based on extensive clinical trial experience
and widespread post-marketing use. The record of safety and effectiveness
of AVANDIA is backed by one of the largest clinical trial programs
(including 52,000 patients) ever undertaken for any medicine.
Data from long-term clinical trials, which offer the most rigorous
scientific measurement of safety and efficacy, provide substantial evidence
to assess the benefit-risk of AVANDIA in treating patients with diabetes.
Importantly, the Public Citizen petition did not include data from the
current Prescribing Information for AVANDIA regarding ADOPT (A Diabetes
Outcomes Progression Trial). ADOPT, the largest head-to-head diabetes
trial, showed that AVANDIA sustained glycemic control longer than metformin
or sulfonylurea, for up to five years. Additionally, outcomes from five
long-term clinical studies did not demonstrate an increased risk of total
mortality for AVANDIA compared to other commonly used oral diabetes
medicines on the market. The current FDA-approved label for AVANDIA states
that the available data are inconclusive on the risk of myocardial
ischemia.
Important Safety Information about AVANDIA(R) (rosiglitazone maleate)
Prescription AVANDIA, along with diet and exercise, helps improve blood
sugar control in adults with type 2 diabetes. Taking AVANDIA with insulin
or nitrates is not recommended.
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.
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.
Before taking AVANDIA, review your medical history and tell your doctor
if you:
-- Have heart failure or other heart problems, or are on any medicines for
high blood pressure, high cholesterol or heart failure, or for
prevention of heart disease or stroke.
-- Take insulin or nitrate medicines.
-- Have a type of diabetic eye disease called macular edema.
-- Have liver problems or had liver problems while taking REZULIN(R)
(troglitazone).
-- Are pregnant or planning to become pregnant.
-- Are breastfeeding or planning to breastfeed.
Women taking AVANDIA should know that AVANDIA may increase the risk of
pregnancy. More fractures have been observed in women taking AVANDIA. Other
possible side effects of AVANDIA include anemia and hypoglycemia. Your
doctor should do blood tests to check your liver before you start AVANDIA
and during treatment as needed.
For more information about AVANDIA, please see Medication Guide. For
further information on AVANDIA, please see full Prescribing Information at
http://www.AVANDIA.com.
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.