FDA panel: Keep Glaxo's Avandia on the market

July 14, 2010 9:19:44 PM PDT
A majority of federal health experts has voted to keep the controversial diabetes pill Avandia - made by Triangle area employer GlaxoSmithKline - on the market despite evidence that it increases the risk of heart attack. A panel of Food and Drug Administration advisers voted 20-12 against withdrawing GlaxoSmithKline's once-blockbuster drug. Panelists who voted to keep the drug on the market were split between several options, including adding new warning labels and restricting use of the drug.

The Food and Drug Administration has convened the panel to help untangle reams of conflicting data over whether the GlaxoSmithKline drug increases heart risks.

Despite an earlier vote that Avandia increases heart risks, panelists said the evidence wasn't strong enough to remove it from the market.

But a 49-year-old Apex man, Gary Register, says he's had two heart bypass surgeries and countless other procedures after he started taking Avandia 10 years ago.

He says that's why he wants the FDA to dig deeper, before making a decision on the future of the drug.

"I was told that the drug had no side effects and that it was going to be the miracle cure for diabetes," he said.

But Register says seven months after he started taking it; he received a grim diagnosis after going to the hospital for what he thought was bronchitis.

"(The doctor) told me I'd had a severe heart attack, not to get up, not to talk, not to do anything," he said. "On my 40th birthday I came home from the hospital and I had bypass surgery."

Register is currently recovering from his most recent heart surgery. He says he does not have a family history of heart problems and believes Avandia is to blame.

"If I could go back and not take the drug, you couldn't force it down me," Register said. "The only people that are going to feel any consequences of the warning label are going to be the ones that have the heart attack."

That's why he wants to see the diabetes drug taken off the shelves. But scientists with GSK question the assertion that Avandia is dangerous.

"There is no evidence to suggest that the use of Rosiglitazone increased the risk of cardiovascular morbidity," Dr. Murray Stewart with GlaxoSmithKline said.

"Any of the people on the Food and Drug Administration that'd like to come and stay at my house, see me walk around, get to know me, and then make a decision," Register said.

In the meantime, Register is part of a class-action lawsuit against GSK, but he says it is not for the money, because it can never replace the hardship for his wife and son.

Meanwhile, the FDA still has the final say. It can reject or adopt the panel's recommendation. It is unclear when they'll have a decision.

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