GlaxoSmithKline (GSK) confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions (20) to withdrawal from the U.S. market (12).

“GSK Australia continually works with the TGA ensuring that all relevant information on Avandia is shared in a transparent and timely manner. It is our belief that the current label in Australia helps doctors to use the medicine in appropriate diabetes patients,” Dr Camilla Chong, Medical Director said.

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.

Following today’s recommendations GSK will continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease.

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered by the FDA in making its final decision. Pending the FDA’s decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.

Dr Camilla Chong said “GSK is dedicated to sharing data about its medicines transparently and in a timely manner. We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, doctors and patients.”

Avandia is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients. The company has consistently shared data with the FDA and other regulators including the TGA and have worked with the agencies to update the product information for Avandia as new data becomes available.

GSK’s view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines. Results from six controlled clinical trials have been reported since the FDA last reviewed questions about the cardiovascular safety of Avandia in 2007. When used in the appropriate patients and in accordance with label approved by the TGA, Avandia remains an effective treatment option for type 2 diabetes.

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

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