For now, Avandia is the new Vioxx.

The New York Times poked around the FDA web site and unearthed a letter written in 2000 by John Buse, chief of endocrinology at the University of North Carolina in Chapel Hill, who is about to become the president of the American Diabetes Association.

He cited “a worrisome trend in cardiovascular deaths and severe adverse events” among patients using the drug. He also accused Glaxo of “pervasive and systemic” attempts to minimize Avandia’s risks and overstate its benefits.

What else was found? A warning letter issued by the FDA to Glaxo in 2001, chastising the drugmaker for distributing materials at an endocrinolgoy convention that didn’t carry warnings on the Avandia label, which were ordred by the FDA to highlight heart and liver risks.

Buse wrote his letter in response to an FDA citizen’s petition filed by Public Citizen’s Sid Wolfe, who asked the agency to place warning labels on Rezulin, Avandia and Actos.

Referring to Avandia by its generic name, rosiglitazone, and to Rezulin as troglitazone, Dr. Buse wrote in the letter, “I do not believe that rosiglitazone will be proven safer than troglitazone in clinical use under current labeling of the two products.” He added: “In fact, rosiglitazone may be associated with less beneficial cardiac effects or even adverse cardiac outcomes.”

However, The Times omitted this interesting sentence by Buse about Rezulin: “To summarize, I believe that we may one day discover that troglitazone is the most effective, safe and beneficial drug in its class.”

Hmm….Anyone recall what happened to Rezulin? Hint: you can’t get a prescription anymore.

Further reading…
The New York Times;
the Buse letter to the FDA;
the FDA warning letter to Glaxo.
[tags]Avandia, GlaxoSmithKline, John Buse[/tags]