After a debate that has divided officials within the US Food and Drug Administration (FDA), an advisory committee to the federal agency yesterday voted to keep the diabetes drug Avandia (rosiglitazone) made by GlaxoSmithKline on the market. This was just after the same panel had overwhelmingly decided that the drug raised the risk of heart attack and other heart problems.
Avandia is an oral drug in the thiazolidinedione class that is taken by around 1 million Americans with type 2 diabetes to control their blood sugar.
This decision comes in the wake of research studies that found Avandia increased the risk of heart attacks and cardiovascular events by up to 40 per cent in patients with type 2 diabetes.
The chairman of the FDA advisory committee, Dr Clifford J Rosen of St. Joseph Hospital in Bangor, Maine, explained that nearly everyone on the panel agreed there was a risk of heart attack from taking Avandia. (The vote was 22 to 1 in favour of this view, contrasting with the 20 to 3 vote to keep the drug on the market).
Rosen also said that patients with congestive heart failure, a history of cardiovascular disease, or who are taking insulin or nitrates should not be given the drug. He predicted there “are going to be changes in the way this is promoted and certainly in how physicians use this drug,” according to the New York Times yesterday.
While the FDA does not have to follow the advice of its advisory committees, it usually does, especially when the vote is a large majority.
Experts have said it’s likely the drug will have to carry new “black box” warnings to limit its prescription to patients with heart problems. Rosen said he hoped the panel decision sent “a clear signal”.
Some FDA officials have called for Avandia to be taken off the market. Dr David Graham, a drug safety officer with the agency, said that for every month the drug continues to be used, some 2,000 patients are likely to have heart attacks and strokes, and some of them will die.
Another senior FDA official, Dr Gerald Dal Pan, who directs the FDA’s surveillance and epidemiology office also thought Avandia should be taken off the market, but he qualified this to be a “personal” view rather than an official view.
Dr Robert Meyer, who directs the new drug evaluation department in the FDA that originally approved the drug thinks it should continue to be available, although he said there was disagreement in the agency about whether the evidence was sufficient, according to a report in WebMD.
GlaxoSmithKline said none of the studies submitted to the FDA showed that patients on Avandia were at greater risk of dying compared with other drugs and placebo.
After the meeting panel members expressed their frustration about the lack of clarity in the evidence submitted.
The panel eventually concluded that removing Avandia from the market would deny a benefit to patients with few other options and in the long run it was probably better to keep it.
it is likely that FDA experts will consider changing the warning on the drug to advise doctors not to prescribe Avandia to patients with cardiovascular disease or congestive heart failure. They are also likely to advise against its use for patients who have been on insulin for a long time, or for those patients with angina who are taking nitrate based medication.
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Written by: Catharine Paddock