Medication Safety Alert

August 15, 2007

MEDICATION:	Avandia® (rosiglitazone), Avandamet® (rosiglitazone maleate and metformin hydrochloride) and Avandaryl® (rosiglitazone maleate and glimepiride) GlaxoSmithKline. Actos® (pioglitazone) and Duetact® (pioglitazone hydrochloride and glimepride) Takeda.
DOSAGE FORM:	Oral Tablets
STRENGTHS:	All Strengths
ISSUE:	FDA issues updated label with a boxed warning on the risks of heart failure for the entire thiazolidinedione class of antidiabetic drugs

The following was posted on the FDA News web site on August 14, 2007:

"After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. These drugs are used in conjunction with diet and exercise to improve blood sugar control in adults with type 2 (non-insulindependent) diabetes. Manufacturers of certain drugs have agreed to the upgraded warning.

The strengthened warning advises healthcare professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their healthcare providers to discuss alternative treatments."

An excerpt of the FDA news article dated August 14, 2007 from the same web site states:

"The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood. The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).

The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

FDA's review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks)."

Please also previous RxAmerica, LLC Drug Alert on this similar topic dated May 21, 2007.