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An FDA advisory panel has found that available data shows that type 2 diabetes drug Avandia increases heart attack risk.
Diabetes in Focus reported in February that the US Senate had issues a scathing report on GlaxoSmithKline's (GSK) handling of research into the heart attack risks of type 2 diabetes drug Avandia (rosiglitazone). The report found ‘GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.’
Since that report was released, there has been a great deal of media attention on the risks associated with Avandia, and whether the FDA would take action to ban it.
WebMD reports that on July 14, a 33 member FDA advisory panel voted on a number of recommendations relating to Avandia.
The majority of the panel believed that while available data suggests that Avandia increases risks of heart attacks more than other classes of diabetes drugs, it doesn’t show that Avandia increases risk of death more than other classes of diabetes drugs.
Because of the limitations of the available data, the panel voted to continue a clinical trial which is comparing Avandia to its competitor Actos.
The next step for the FDA is to make a decision based upon these recommendations.
Why is this important?
80,000 Australians use Avandia, according to the ABC.
The Theraputic Goods Administration ( TGA) in Australia is meeting with the makers of Avandia, GlaxoSmithKline, to determine if current Australian warning labels and guidelines need to be changed.
Diabetes Australia reports that they, 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.
Diabetes Australia acting CEO Greg Johnson adds “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.”
This statement may be a reference to Actos, which is in the same class of diabetes drugs as Avandia, but which has not been shown to increase the risk of heart attacks.
Diabetes Australia Media Release ‘Avandia - Latest News’
http://www.diabetesaustralia.com.au/Media-Centre/Media-Releases/Avandia---Latest-News/
WebMD ‘FDA Panel Splits Over Avandia Ban’
http://diabetes.webmd.com/news/20100714/fda-panel-splits-over-avandia-ban?page=2
ABC radio PM program 'Diabetes Drug Concerns after More Heart Attacks'
http://www.abc.net.au/pm/content/2010/s2827038.htm
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