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Stronger Heart Warning on Diabetes Drugs

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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.

Which Drugs Will Receive the Warning?

The upgraded warning emphasizes that the following medications in the class of antidiabetic drugs (thiazolidinediones) may cause or worsen heart failure in certain patients:

• Avandia (rosiglitazone)
• Actos (pioglitazone)
• Avandaryl (rosiglitazone and glimepride)
• Avandamet (rosiglitazone and metformin)
• Duetact (pioglitazone and glimepride)

These drugs are used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes.

What Does the Warning Mean?

• Addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure.
• Advises health care professionals to watch patients carefully for signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and swelling (edema), after starting drug therapy.
• Advises patients with these symptoms to seek immediate medical attention. Patients with questions about starting or continuing use of these drugs should contact their health care professional to discuss their individual treatment options.
• States that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity, are comfortable only at rest, or are confined to bed or a chair.

Concerns about Heart Failure vs. Heart Attacks

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

Related Information

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

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