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Consumer Update |
FDA announced today that manufacturers of certain drugs approved to treat type 2 (non-insulin-dependent) diabetes have agreed to add the agency's strongest warning--"boxed"--on the risk of heart failure. This cardiovascular condition occurs when the heart does not adequately pump blood.
The upgraded warning emphasizes that the following medications in the class of antidiabetic drugs (thiazolidinediones) may cause or worsen heart failure in certain patients:
These drugs are used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes.
The boxed warning action above is a separate issue from FDA's ongoing review of Avandia and the possible increased risk of heart attacks (ischemic risks). But the two issues are often confused.
The agency's Endocrine and Metabolic Advisory Committee and Drug Safety and Risk Management Advisory Committee recommended on July 30, 2007, that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks). FDA also will provide updates on this issue as information becomes available.
For more information on rosiglitazone and pioglitazone
www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
www.fda.gov/cder/drug/infopage/pioglitazone/default.htm
FDA Press Release (August
14, 2007)
FDA Press Release (May
21, 2007)
New Safety Information
on Diabetes Drug Rosiglitazone (May 25, 2007)
Date Posted: August 15, 2007