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GlaxoSmithKline to revise Avandia® (rosiglitazone maleate) label in Europe following assessment by CHMP


GlaxoSmithKline (GSK) announced today that it will revise its European label for Avandia® (rosiglitazone maleate). The EMEA’s Committee for Medicinal Products for Human Use (CHMP) completed a positive benefit risk review of the thiazolidinediones (TZDs) including rosiglitazone in October 2007 and these label amendments are the result of this process.

“The EMEA has previously concluded that the benefits of rosiglitazone continue to outweigh its risks. The revisions to the rosiglitazone label resulting from this review will provide some additional guidance to physicians prescribing rosiglitazone,” said Dr Alastair Benbow, Vice President and European Medical Director, GSK.

The label will be revised to state that available data indicate that rosiglitazone may be associated with an increased risk of myocardial ischaemic events. It will also state that this risk was not confirmed or excluded in three long-term clinical trials and the data in their entirety on myocardial ischaemia are inconclusive.

There are limited clinical trial data in patients with ischaemic heart disease and/or peripheral arterial disease, especially those with myocardial ischaemic symptoms. The revised label will state that as a precaution, the use of rosiglitazone is not recommended in these patients. This information will appear in the warnings and precautions section of the label.

Patients with acute coronary syndrome (unstable angina, NSTEMI and STEMI) require urgent hospital treatment and have an increased risk of developing heart failure. This high-risk patient population has not been studied in rosiglitazone controlled clinical trials, and revised labelling will advise prescribers that rosiglitazone is contraindicated in patients with acute coronary syndrome.

“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 has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines, metformin and glibenclamide (a sulfonylurea) – for nearly five years. Rosiglitazone is a valuable medicine for many patients with type 2 diabetes and remains an important treatment option for physicians.” added Dr Benbow.

The label changes will be applied to all approved rosiglitazone-containing products: Avandia ® (rosiglitazone maleate), Avandamet ® (rosiglitazone maleate and metformin hydrochloride) and Avaglim ® (rosiglitazone maleate and glimepiride).

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Editor’s note:

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 appropriateness.

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 current rosiglitazone prescribing information states that rosiglitazone has been associated with an increased risk of myocardial ischaemia in a retrospective meta-analysis. This is not reflected in an epidemiology study of over 33,000 patients.

The above information reflects the current SPC for rosiglitazone in Europe. The EMEA have provided additional updates regarding the rosiglitazone label in an 18 October 2007 and 24 January 2008 press statement that can be accessed via the EMEA website.
This press release is intented for business journalists and analysts/investor. Please note that this release may not have been issued in every market in which GSK operates.
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