Panel: Diabetes Drug Needs More Warnings
MARY LOUISE KELLY, Host:
NPR's Richard Knox reports.
RICHARD KNOX: In the end, the doctors and patients on the FDA's advisory panel said that Avandia's a useful drug that should remain available to people with Type 2 diabetes, which mainly affects older adults. Rebecca Killian was the consumer representative on the panel.
REBECCA KILLIAN: This drug helps obtain glucose control, and for diabetics that's our holy grail. That is what we live with every day. And so it's important for diabetics to have as many arrows in the quiver as possible.
KNOX: All in all, the data were not strong enough for most panel members, including San Francisco heart specialist John Teerlink, who reluctantly voted to keep the drug on the market.
JOHN TEERLINK: I think we need to have stronger evidence to remove the drug.
KNOX: Twelve out of the 33 committee members said Avandia should come off the market and many others said they came very close to that position.
CLIFF ROSEN: I think a lot of us had that same feeling, that this was really very borderline.
KNOX: That's Dr. Cliff Rosen of Maine Medical Center in Portland. He was one of 10 panel members who voted to keep Avandia, known by the generic name rosiglitazone, on the market.
ROSEN: So my headlines would be that rosiglitazone has significant risk for heart attacks and that there is still consistent worries about continuing to use this drug.
KNOX: Rosen said he voted to keep it on the market only if the FDA can come up with a way to make sure that the only patients who get the drug are the ones who don't do well on other drugs for diabetes.
ROSEN: I strongly feel that it's got to be very tightly restricted if it stays on. I would be extremely disappointed if they didn't have a very tight hold on who could prescribe this medication and make sure that everybody understood the risks involved.
KNOX: Richard Knox, NPR News.
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