Data support Avandia (rosiglitazone maleate) cardiovascular safety profile

10 Jul 2010 - Data support Avandia (rosiglitazone maleate) cardiovascular safety profile

The U.S. Food and Drug Administration (FDA) today posted a comprehensive review conducted by GlaxoSmithKline (GSK) of the cardiovascular safety data on Avandia® (rosiglitazone maleate).

The data in GSK’s review come from meta-analyses, observational studies and large controlled clinical trials that have become available since July 2007, when the FDA convened advisory committees to review the efficacy and safety of rosiglitazone . The FDA’s Endocrinologic and Metabolic Drugs, and the Drug Safety and Risk Management Advisory Committees will review these data at a meeting on 13-14 July 2010.

A three-page executive summary of GSK’s briefing document for the FDA meeting and a copy of the complete briefing document is posted on the FDA’s website.

In Australia, the safety and effectiveness of Avandia is well characterised in the label approved by the TGA1 ensuring that the appropriate patients are receiving the medicine.

The FDA Advisory Committees is scheduled to convene 13-14 July to review all the latest available data on Avandia.

Dr Tony Hoos, European Medical Director for GlaxoSmithKline said: “GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients. It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients. Patients should not stop taking rosiglitazone, or any other medicine for type 2 diabetes, without consulting their doctor.”

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 further information please visit www.gsk.com.au

References

1 Avandia Product Information

Minimum Product Information

Avandia is used to treat patients with type 2 diabetes mellitus and can be used alone (when diet and exercise is not enough to treat your diabetes) or together with other anti-diabetic medicines. Avandia is not recommended in patients with known ischaemic heart disease, particularly in those taking nitrates. Avandia must not be used if people have had an allergic reaction to Avandia or its ingredients, heart failure, history of cardiac failure, or Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI). You must tell your doctor if:
• you are breastfeeding, pregnant or trying to become pregnant. Your doctor will decide if this medicine is suitable for you.
• you have heart failure or have had heart failure in the past.
• you have breathing difficulties.
• you have a history of swelling or pain of legs and feet.
• you have a problem with your liver. The medicine may remain in your body longer than usual.
• you have visual disorders.
• you are taking insulin.
• you are taking nitrates for existing heart disease because heart problems such as angina and heart attack have been reported.
• you are taking other anti-diabetic medications. The dose of these other medications may need to be decreased to reduce any risk of hypoglycaemia (low sugar levels in the blood).
• you have polycystic ovary syndrome. Due to the way your medicine works there may be an increased risk of pregnancy.
• you are allergic to foods, dyes, preservatives or any other medicines.
• you are taking any other medicines, including medicines you buy without a prescription.

Broken bones, usually in the hand, upper arm or foot, have been seen with rosiglitazone use in women. Talk to your doctor for advice on how to keep your bones healthy. Avandia only works in the presence of the body’s own insulin therefore it should not be used in patients with type 1 (or insulin dependent) diabetes mellitus.

A copy of the Avandia Consumer Medicine Information and Product Information can be accessed at http://www.gsk.com.au/avandia

For further information:

Lisa Maguire
Phone: 03 9721 6637
Mobile: 0449 950 745

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GlaxoSmithKline Australia Pty Ltd, 1061 Mountain Hwy Boronia Victoria 3155. ABN 47 100 162 481. Avandia® is a registered trade mark of the GlaxoSmithKline Group of Companies.