Avandia, a type-2 diabetes drug linked to serious cardiovascular complications including: heart attack and heart failure.
 What is Avandia?
Avandia is an oral diabetes medicine that help control blood sugar levels. Avandia is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes. Avandia may also be used for purposes other than those listed in Avandia's medication guide.
Avandia History
A report was developed over the last 2 years by U.S. Senate Committee on Finance investigators who reviewed over 250,000 pages of documents provided by Avandia’s pharmaceutical drug maker GlaxoSmithKline, the FDA, the University of North Carolina, and others. Committee investigators also conducted numerous interviews and phone calls with GSK, the FDA, and anonymous whistleblowers.
Committee staff began this investigation in May 2007 after a study was published in the New England Journal of Medicine, showing a link between the diabetes drug Avandia (rosiglitazone) and heart attacks. However, the reviewed evidence suggests that GSK knew for several years prior to this study that there were possible cardiac risks associated with Avandia.
As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns. Instead, 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.
When an independent scientist sought to publish a study in 2007 pointing out the cardiovascular risk of Avandia, GSK acquired a leaked copy of that study from one of its consultants prior to the study being published. The company’s own experts analyzed the study, found it to be statistically reliable, and then attacked the soundness of that study in press releases and public comments.
GSK also sought to counter the study’s findings by quickly releasing preliminary results from its own study on Avandia, even though the company’s internal communications established that its study was not primarily designed to answer questions about cardiovascular risk.
Recent Avandia Updates
 FDA Report: Take Avandia Off the Market
02.19.10 | The New York Times
February 19, 2010 --Two officials from the Food and Drug Administration are recommending that diabetes drug Avandia be pulled from the market because of its potential to harm the heart, the New York Times reports. Agency reports suggest that if every diabetic taking Avandia switched to a different medication, about 500 heart attacks would be averted each month. And in the third quarter of 2009, Avandia was linked to 304 deaths, the Times reports. Avandia's heart risks came to light following a 2007 study by the Cleveland Clinic, but later studies failed to show a definitive link. An FDA advisory committee is being assembled to assess whether or not Avandia should continue to be sold.
Read Full Article Here.
Pharmaceutical Giant GlaxoSmithKline to Suffer More Setbacks in Avandia Battle
02.03.10 | The Sanders Firm Press Release
February 3, 2010 -- Pharmaceutical giant GlaxoSmithKline is about to suffer more setbacks in the ongoing battle of opinions concerning the safety of its much touted diabetes drug Avandia. The American Diabetes Association has accepted for publication in its prestigious medical journal, Diabetes Care, a study by Harvard researchers that shows users of the diabetes drug Avandia have more than double the risk of a heart attack compared to other diabetes drugs. Further, a jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety, an independent drug-safety firm, will appear in the journal Clinical Therapeutics showing that Avandia users have a 35-41% increased risk of a heart attack over users of Actos, Avandia's main competitor.
Read Full Article Here.
Doctors Claim Glaxo Dismissed Worries on Avandia
Drug Maker Tried to Make Physician at Maryland Hospital Stop Talking About Concerns; Company Defends Its Effort
11.19.08 | The Wall Street Journal
A ruckus erupted last year when reports surfaced that Glaxo was accused of intimidating John Buse, a University of North Carolina researcher who, years earlier, questioned the safety of its Avandia diabetes pill, which was linked to heart problems. However, he wasn’t the only one the drug maker tried to stifle. Read Full Article Here.
Public Citizen Petitions FDA to Ban Diabetes Drug Avandia, According to Avandia Plaintiffs Attorney Group
11.6.08 | LexisNexis Press Release
National non-profit organization documents upsurge in negative clinical data associated with use of Avandia, urges FDA commissioner to remove drug from U.S. market immediately Thus, it is urgent for the FDA to immediately ban rosiglitazone (Avandia). Read Full Article Here.
Diabetes Drug Makes Body Reabsorb Bone, Making Bones Weaker
12.3.07 | Medical News Today
Avandia, a drug for treating diabetes type 2, encourages the body to reabsorb bone, making them weaker and more likely to break, say experts. Avandia, a top selling drug, is made and marketed by GSK (GlaxoSmithKline).
Studies had previously indicated that Avandia raised the risk of developing bone fractures among women. A new report, published in Nature , confirms this, it also explains why this is so. The drug, say scientists, boosts the action of osteoclasts, cells that weaken bones.
According to team leader, Professor Ronald Evans, the Salk Institute for Biological Studies , La Jolla, California, there is a delicate balance between the deposition of new bone and the removal of old bone. Every bit of bone that is taken away should be counteracted by the same amount of new bone added, he explained. With Avandia, however, cells that take bone away are stimulated, while cells that create bone are calmed down - the result being that the body destroys bone faster than it is replenishing it.
Evans stressed that patients should not immediately go off Avandia. There are drugs that can make up for this bone loss. Rather, he says, patients should be carefully monitored.
Avandia has also been associated with raised heart attack risk. The drug will carry a black box warning about heart attacks and chest pains in the USA.
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