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Microsoft word - eu press release 14 nov avandia1.doc
GSK Revises US Labeling for Avandia
November 14, 2007 -
— GlaxoSmithKline announced today that it is implementing changes to the
US product label for Avandia (rosiglitazone maleate), based on an extensive and thorough review
by the FDA of myocardial ischaemia
data on rosiglitazone, 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
rosiglitazone and an increase in myocardial ischaemic events, that risk was not confirmed or
excluded in three long-term clinical trials comparing rosiglitazone against both placebo and other
oral anti-diabetes medicines. The box will state that the available data on the risk of myocardial
ischaemia 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 rosiglitazone or any other oral antidiabetic drugs.” - will be added as a warning on
the labels of all oral anti-diabetic medicines.
The rosiglitazone label also has been updated to add that rosiglitazone is not recommended -
though not contraindicated - for use with patients who are taking insulin or nitrates. The label
summarizes the data on myocardial ischaemia to help doctors continue to evaluate which patients
could benefit from taking rosiglitazone, and those for whom alternative treatment should be
The changes are now included in labelling for rosiglitazone in the US, and will be incorporated into
future revised labelling for all approved rosiglitazone-containing products, i.e. Avandamet
(rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and
glimepiride). GSK is also preparing a Medication Guide to help educate US patients about
potential benefits and risks and to provide other information on rosiglitazone.
“Avandia remains a valuable medicine for many patients with type 2 diabetes, and when used
according to the labelling, has a well described and appropriate safety and efficacy profile,” said
Dr. Ronald Krall, GSK Chief Medical Officer. “Given the severity of this disease and the
importance of rosiglitazone in helping patients manage their diabetes, we will continue to work
with the FDA to conduct more studies on the safety and benefits of our medicine.”
As previously stated by GSK, two long-term trials in patients with diabetes comparing
rosiglitazone 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
ischaemic 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 rosiglitazone 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 people with pre-diabetes (DREAM). The
combined analysis of these three studies show there was no increased risk of rosiglitazone over
comparators with regard to myocardial infarction, mortality, or other non-heart failure
In Europe, no agent, including rosiglitazone, is currently approved for the treatment of pre-diabetes.
GSK believes data from ongoing and future clinical trials will provide additional scientific support
for both the benefit and safety of rosiglitazone. GSK has agreed to work with the FDA to plan and
carry out a clinical trial to further investigate the cardiovascular effects of rosiglitazone.
Rosiglitazone has been prescribed to more than seven million people in the US over the last
seven years to help them control their blood sugar levels. Importantly, rosiglitazone has been
shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines
(metformin and SU) – for nearly five years. Long-term glycaemic control is important to help
prevent the serious complications of diabetes, especially microvascular complications leading to
blindness, amputation and kidney failure. Rosiglitazone 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. Important Information for Avandia (rosiglitazone maleate) in Europe
Rosiglitazone helps improve blood sugar control in Type 2 diabetes. It may be taken alone by
diabetic patients who cannot take metformin, in combination with metformin or a sulphonylurea, or
with both metformin and a sulphonylurea. It is contraindicated for use in combination with insulin.
Rosiglitazone is also contraindicated for patients with cardiac failure and may cause fluid
retention. Patients with sudden rapid increase in weight, increasing edema or shortness of breath
should consult their doctor.
An increased risk of bone fracture has been seen in women taking rosiglitazone. The majority of
the reported fractures occurred in the hand, foot and arm.
Patients with liver impairment should not take rosiglitazone. Blood tests should be used to check
for liver problems before starting treatment, and periodically after that according to clinical
Caution is advised when using rosiglitazone in patients with significant renal impairment.
Rarely, some people have experienced vision changes due to swelling in the back of the eye
while taking rosiglitazone
When used in combination therapy, particularly with sulphonylurea, hypoglycaemia may occur.
Dose reduction of concomitant diabetes therapy may be required.
Rosiglitazone may increase the likelihood of pregnancy. Where appropriate, patients should seek
contraceptive advice from their doctor prior to commencing therapy.
Rosiglitazone is contraindicated while breast feeding.
The above information reflects the current SPC for rosiglitazone in Europe. The EMEA have
provided additional updates regarding the rosiglitazone label in an 18 Oct press statement that
can be accessed via the EMEA website.
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