• Home
• For Patients and Caregivers
• Glossary
• Print this page

For Healthcare Professionals

On November 14, 2007, GlaxoSmithKline (GSK), the maker of Avandia, announced that it was implementing changes to the product label for Avandia. The existing boxed WARNING was expanded to highlight a potential increased risk of myocardial ischemic events.

This revision followed a full and scientific review at the FDA following the July 30, 2007 Advisory Committee meeting.

FDA concluded that there is not enough evidence to show that the risks of heart attack or death are different between Avandia and some other oral type 2 diabetes medicines. Therefore GSK has agreed to work with FDA to conduct a new long-term study to further review cardiovascular effects of Avandia.

No oral type 2 diabetes medication has been conclusively shown to reduce cardiovascular risk; therefore, FDA will request that the labels of all oral type 2 diabetes medications contain language describing the lack of data showing this benefit.

Avandia is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes as either monotherapy or as combination therapy.

CONTRAINDICATION:

• Initiation of Avandia in patients with established New York Heart Association (NYHA) Class III or IV heart failure

Important Limitations of Use

• Coadministration of Avandia and insulin is not recommended
• Use of Avandia with nitrates is not recommended

Boxed WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL ISCHEMIA

• Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients. Observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these develop, the heart failure should be managed according to current standards of care. Discontinuation or dose reduction of Avandia must be considered
• Avandia is not recommended in patients with symptomatic heart failure
• A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 total patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive

OTHER WARNINGS AND PRECAUTIONS

• Initiation of Avandia is not recommended for patients experiencing an acute coronary event and discontinuation of Avandia during this event should be considered
• Dose-related edema, weight gain, and anemia may occur
• Avandia should not be started in patients with active liver disease or with ALT levels >2.5X the upper limit of normal. Check liver enzymes prior to initiation of Avandia and periodically per clinical judgment
• Macular edema has been reported
• Increased incidence of bone fracture in female patients
• Resumption of ovulation can occur