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Diabetes Drug Should Stay Despite Heart Risks, U.S. Advisers Say
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Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >> While the FDA isn't bound to follow the recommendations of its advisory panels, it typically does so.
Following the vote, Glaxo issued a statement from Dr. Ronald Krall, the company's chief medical officer. "We welcome this decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia," he said. "The committee recognized the debilitating nature of this disease and the importance of multiple treatment options. Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients."
Concerns about Avandia (rosiglitazone), part of a class of drugs for diabetes called thiazolidinediones, are based on a meta-analysis of published studies that suggested the drug increases the risk of heart attack by 43 percent.
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That finding was first published May 21 in the New England Journal of Medicine, in a paper co-authored by Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and one of the earliest critics of the arthritis drug Vioxx, which was withdrawn from the market in 2004 due to heart attack concerns.
Dr. Larry Deeb, president for medicine and science at the American Diabetes Association, said before Monday's vote that he believes Avandia should continue to be available to diabetics because the increased risk of heart attack has not been proven conclusively.
"A decision to do something should not be based on a nebulous risk," Deeb said. "There probably should be a warning on the box, because there is enough concern."
Deeb believes the FDA should call for a study to thoroughly review any heart risks associated with the drug's use. "It's premature to withdraw the drug. I am anxious about pulling [a drug] that has done some good off the market based on a meta-analysis," he added.
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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 7/31/2007
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SOURCES: July 30, 2007, U.S. Food and Drug Administration teleconference with Robert Meyer, M.D., director, FDA's Office of Evaluation II, Center for Drug Evaluation and Research; and
Clifford Rosen, M.D., acting committee chairman, Maine Center for Osteoporosis, St. Joseph Hospital, Bangor, Maine; and Gerald Dal Pan, M.D., director of the FDA's Office of Surveillance and Epidemiology;
Larry Deeb, M.D., president, medicine and science, American Diabetes Association, Alexandria, Va.; Andy Zambanini, M.D., director, clinical development, GlaxoSmithKline; July 30, 2007, prepared statement, Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, Washington, D.C.; July 30, 2007, prepared statement, GlaxoSmithKline
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