10 september 2009

Diabetes Leaders Urge Patients to Talk with their Doctor before Making Changes
to their Medication Use
Diabetes Australia, the Australian Diabetes Society and the Australian Diabetes
Educators Association issued a joint statement 16 July 2010 in response to the
US Food and Drug Administration panel’s recommendation to keep rosiglitazone
(Avandia) on the market.
The U.S. Food and Drug Administration’s (FDA) Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has completed their evaluation of the scientific research available on the safety of rosiglitazone. The deliberations of the panel reflected the complexity of the issues with the final recommendation to allow Avandia to remain on the market. Now that the expert panel has concluded its meeting, the FDA will review their recommendations and make the final decision on whether the drug remains available to patients. In Australia, the safety and effectiveness of Avandia is detailed in the label approved by the Therapeutic Goods Administration (TGA), helping to ensure that the appropriate patients are receiving the medicine. In fact if the new FDA recommendations are adopted they may tighten indications for use of Avandia in the USA to the more stringent levels that currently exist for prescribing of Avandia in Australia. Also in Australia the TGA Committee is expected to review and discuss data with the Pharma company producing Avandia, Glaxosmithkline, during a meeting scheduled for 19-22 July, 2010. Even with the FDA panel’s recommendation, the amount of scrutiny the drug has received may lead some diabetes patients who currently take rosiglitazone to want to stop taking the drug. Diabetes Australia, the Australian Diabetes Society and the Australian Diabetes Educators Association urge patients to not make any changes to their medication use without discussing their treatment with their physician. “Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,” said President of Australian Diabetes Society Associate Professor Stephen Twigg. “Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.” diabetesaustralia.com.au
Level 2 103-105 Northbourne Avenue, TURNER ACT 2612, Australia GPO
Box 3156, CANBERRA ACT 2601, Australia
T: +61 2 6232 3800. F: +61 2 6230 1535. E: [email protected] ABN
Patron - Her Excellency Ms Quentin Bryce AC Governor-General of the Commonwealth of Australia - turning diabetes around
awareness • prevention • detection • management • cure “Patients are at increased risk of diabetes related complications if diabetes is not able to be managed adequately, but there are many treatment choices that can be considered in discussion with their health care provider,” said the Australian Diabetes Educators Association President Heather Hart. Reports regarding the cardiovascular safety of rosiglitazone have not been definitive. While some analyses have suggested an increased cardiovascular risk with use of the diabetes drug others have not shown substantial evidence of such an association. “Patients should be aware that regardless of the opinion and decisions on rosiglitazone, there are numerous drugs available to maintain glucose control in people with type 2 diabetes. Patients should discuss these options with their health care providers,” said Diabetes Australia Acting Chief Executive Officer Greg Johnson. Diabetes Australia is a national federated body made up of state and territory
organisations supporting people with diabetes and those professional and research
bodies, particularly concerned with the treatment and prevention of diabetes. Our
purpose is to help all people affected by diabetes and those at risk and to contribute to
the search for a cure. Diabetes Australia works in partnership with diabetes health
professionals and educators, researchers and healthcare providers to minimise the
impact of diabetes on the Australian community.
The Australian Diabetes Society was formed in 1973 and is the peak medical and
scientific body in Australia working towards improving the care and outcomes of people
with diabetes. It is an incorporated association and is made up of its members.

The Australian Diabetes Educators Association (ADEA) was formed in 1981 and is
the leading Australian organisation for health care professionals providing diabetes
education and care. The ADEA actively promotes evidenced-based best practice
diabetes education to ensure optimal health and well being for all people affected by,
and at risk of, diabetes. The ADEA considers diabetes education a specialty field of
health care practice.
Statement on potential conflict of interest: Associate Professor Stephen Twigg undertakes occasional consultative activities such as educational lectures, on behalf of a range of Pharma companies in diabetes, including the producers of Avandia, GSK. diabetesaustralia.com.au
Level 2 103-105 Northbourne Avenue, TURNER ACT 2612, Australia GPO
Box 3156, CANBERRA ACT 2601, Australia
T: +61 2 6232 3800. F: +61 2 6230 1535. E: [email protected] ABN
Patron - Her Excellency Ms Quentin Bryce AC Governor-General of the Commonwealth of Australia - turning diabetes around
awareness • prevention • detection • management • cure diabetesaustralia.com.au
Level 2 103-105 Northbourne Avenue, TURNER ACT 2612, Australia GPO
Box 3156, CANBERRA ACT 2601, Australia
T: +61 2 6232 3800. F: +61 2 6230 1535. E: [email protected] ABN
Patron - Her Excellency Ms Quentin Bryce AC Governor-General of the Commonwealth of Australia - turning diabetes around
awareness • prevention • detection • management • cure

Source: http://www.diabetesvic.org.au/images/stories/PDF_files/DA%20response%20to%20Avandia.pdf