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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 Currently, there is a warning on Avandia's label that it increases the risk of another cardiovascular problem called congestive heart failure, a chronic condition caused by the heart's failure to pump normally, allowing fluid to build up in the body.
In May, the FDA said it wanted a stronger warning about the risk of heart failure on Avandia's label. Glaxo is "still in negotiation with the FDA about a new warning label on heart failure and we expect to release that information soon," Zambanini said.
Critics of the drug contend there are alternatives to Avandia that don't have the same risk for heart failure or heart attack They include metformin, Actos, Amaryl, Glyburide and others.
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More information
Learn more about diabetes drugs from the U.S. Food and Drug Administration.
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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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