FDA: Risky diabetes drug Avandia should stay

The U.S. Food and Drug Administration announced its decision on Sept 23, via its website to let type 2 diabetes mellitus drug Avandia, made by GlaxoSmithKline, stay on the market even though the drug has been linked to increased heart risk such as myocardial infarction (heart attack) and stroke. 

The FDA said it will significantly restrict the use of Avandia, or rosiglitazone, to patients with type 2 diabetes mellitus who cannot control their diabetes on other medications. 

Earlier, Dr. David Graham, veteran drug safety examiner at the FDA, said there was no reason for the agency to keep the risky diabetes drug on the market, now that another drug Actos, which is in the same class, but much safer, compared to the Avandia. 

Dr. Graham is among a group of experts who recommend that the FDA should ban Avandia and he compared Avandia with Actos and found Actos is safer than Avandia. 

Dr. Steven Nissen, famous cardiologist at the world-famous Cleveland Clinic, conducted a study and published it in 2007 in the New England Journal of Medicine, which links use of Avandia to 43 percent increased risk of heart attack and hospitalization for blocked coronary arteries. 

Dr. Wolfgang C. Winkelmayer at Harvard Medical School, which have most recently found death rates for patients on Avandia were 15 percent higher and congestive heart failure rates were 13 percent higher than those on Actos. 

Dr. Thomas Marciniak, medical team leader at the FDA examined the controversial, open-label trial called RECORD, which is often used to demonstrate diabetes drug Avandia does not raise heart risk, and found numerous errors, biases and mistakes.  Dr. Marciniak suggested the study is not reliable. 

Drs. Graham, Nissen and Marciniak presented their evidence to FDA panelists, but the majority of them voted to recommend that the drug should remain on the market even though the majority agreed the diabetes drug may raise heart attack risk. 

In a 11-page document dated Sept 22, Janet Woodcock MD, director for the Center for Drug Evaluation and Research, explains why she decided to allow Avandia to continue to be on the market. 

Dr. Woodcock says she has reviewed the extensive documentation available on the issue and found "the evidence pointing to a cardiovascular ischemic risk with rosiglitazone is not robust or consistent." 

She says her decision was based on three reasons, first, "the cardiovascular safety profile of rosglitazone is STILL an open questions"; second, there are some diabetes patients who may benefit from Avandia, and third, patients on Avandia may wish to remain on the drug. 

The FDA requires Glaxo to commission an independent re-adjudication of the controversial trial RECORD.  This requirement indicates how unreliable studies by drug companies are, Dr. Nissen said in an interview with CNN. 

Dr. Nissen said the FDA restriction along with the European ban of Avandia may in fact cut the use of this drug by 99 percent. 

Last week, Europe banned Avandia because of the concern about the risk of myocardial infarction and other cardiovascular risk. But the European Medicines Agency will allow the diabetes drug on the market for a few months, considering patients need some time to discuss with their doctors about other therapies.

By Jimmy Downs and editing by Rachel Stockton