FDA Panel: Keep Diabetes Drug on Market Avandia, a pill to treat diabetes, needs strong new warnings about potential heart-attack risks, an FDA panel says. But the panel also said the widely used drug should remain in use.
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FDA Panel: Keep Diabetes Drug on Market

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FDA Panel: Keep Diabetes Drug on Market

FDA Panel: Keep Diabetes Drug on Market

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It's MORNING EDITION from NPR News. Good morning. I'm Steve Inskeep.

We're going to look this morning at a drug that solves one problem but causes another. It's the diabetes drug Avandia. A special advisory committee to the Food and Drug Administration now agrees the drug can cause heart attacks, but they also say the drugs should stay on the market. That split decision means the FDA faces a difficult decision about a popular drug, and it's not the first time that's happened.

NPR's Joanne Silberner has this report.

JOANNE SILBERNER: At yesterday's FDA meeting, it was starting to sound like Vioxx all over again. FDA epidemiologist David Graham presented an analysis that suggested serious problems with the diabetes drug Avandia, often known as rosiglitazone.

DAVID GRAHAM: For every 114 patients that we treat with rosiglitazone for a year, we would produce one extra case of serious coronary heart disease.

SILBERNER: Despite the criticism, manufacturer GlaxoSmithKline is sticking by its drug. Chief medical officer Ronald Krall described three large on-going studies of Avandia that Glaxo is sponsoring. In the studies, doctors are keeping track of the number of heart attacks - myocardial infarctions.

RONAL KRALL: The number of myocardial infarctions is small. The data are inconsistent, and there is no overall evidence that rosiglitazone is different from other oral anti-diabetic agents.

SILBERNER: As it did with Vioxx, Congress has been weighing in. Since the first warnings about the drug were published in the New England Journal of Medicine, legislators have sent letters to the FDA and in June held a hearing to question the agency about why it wasn't moving more quickly to investigate the drug.

Advisory committee members for Avandia, as with Vioxx, complained that the FDA allowed the drug in the market before enough data were collected. And yesterday, committee members repeatedly said the studies they had on hand really weren't enough to determine whether the risk of heart attack is real. David Shade is with the University of New Mexico School of Medicine.

DAVID SHADE: I think if I were a betting person, I'd probably vote for cardiovascular risk for rosiglitazone. I'm not a betting person. Therefore I think the amount I'd bet on it - it certainly wouldn't be my house; more likely my lunch.

SILBERNER: So the committee hedged it bets. It voted 20 to three that there is some heart disease risk, especially for older people, and those on insulin or a class of heart drugs called nitrates. Yet it voted 22 to one to recommend that the agency leave Avandia on the market with some sort of warning on the label about risk of heart disease. One reason was to give doctors and patients choices of diabetes drugs, which are notoriously under-used.

Charlie Stills'(ph) diabetes led to the amputation of one of his legs. He told the committee about his 83-year-old mother who also has diabetes. She had tried other diabetes drugs and stopped because of side effects. She was happy at first on Avandia but...

CHARLES STILLS: Since May, when this became a massive news item, she hasn't taken any medications at all for her diabetes. That worries me. I'd rather see her on a medication with close monitoring for a specific possible side effect than no medication at all.

SILBERNER: While some people want their Avandia, others think the FDA should have taken sharper action against the drug a long time ago. Avandia has been on the market for eight years. At a break during the meeting, FDA official Douglas Throckmorton defended his agency, saying sometimes you don't see problems until many people take a drug.

DOUGLAS THROCKMORTON: In the end, some of this comes down to needing patients to have the drugs and see what experiences they have, and collecting those experiences and trying to incorporate them into the safety pattern for the drug, and that's what we're striving to do here.

SILBERNER: Cleveland Clinic cardiologist Steven Nissen started the public debate back in May with his analysis that found a 43 percent increase in heart attacks. He was an early critic of Vioxx. After listening to yesterday's hearing, he said he still believes Avandia has more risks than benefits, but he wasn't disappointed with the committee's vote.

STEVEN NISSEN: The argument was made very well for why further actions might have been appropriate, but I'm actually satisfied. They, in fact, affirmed the finding that there's increase cardiovascular risk with the drug.

SILBERNER: And he says if the FDA goes ahead and puts a warning on Avandia, doctors will prescribe it less often. It's already started to happen. According to the company, sales of Avandia have dropped 31 percent in the U.S. since Nissen first sounded the alarm in May.

Joanne Silberner, NPR News.

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