FDA Panel Votes to Change Restrictions on Avandia
Controversial decision comes after a second look at major data review focused on heart risks
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Dr. George King, director of research for the Joslin Diabetes Center and a professor of medicine at Harvard Medical School, said Avandia use needs to be restricted but has no problem with the FDA taking a look at the new evidence.
"A reanalysis is always good," King said. "Why spend all that money to do the study if you're not going to consider the data, right?"
King noted that Avandia and other drugs in its class, called thiazolidinediones, occupy a unique place in diabetes treatment. They decrease insulin resistance in the body by binding to receptors in fat cells and making those cells more responsive to insulin.
"We don't have any other diabetic medications that can actually improve insulin resistance," he said. "The others either promote more insulin production from the pancreas, make you urinate out more glucose or help your liver handle glucose better."
On the other hand, thiazolidinediones also cause problems with fluid retention. "In diabetic patients who are older, almost all of them have some kind of cardiovascular problem," King noted. "If you retain fluid, you are going to have increased risk for cardiovascular problems and mortality."
Both sides in the debate have a point, King concluded.
"From my view of it, it does have a niche for use, but the restrictions have to be there," he said. "The people who think it is absolutely safe are absolutely not right, but others who are focused on finding fault with it are overlooking some benefits."