Jane S. Ricciuti, RPh, MS


April 22, 2003

In This Article

Antidiabetic Agents

(rosiglitazone maleate) Tablets

Manufacturer: SmithKline Beecham Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/27/03)

New Indication: This supplemental new drug application for Avandia (rosiglitazone maleate) is approved for the use of Avandia in combination with insulin for the treatment of patients with type 2 diabetes mellitus.

Adverse Effects: In clinical trials with Avandia and insulin, patients with preexisting edema were more likely to have adverse events associated with edema.

In 26-week double-blind clinical studies, edema was reported with higher frequency in the Avandia plus insulin combination trials (insulin, 5.4%; and Avandia in combination with insulin, 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at rates of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with Avandia.

Avandia (rosiglitazone maleate) Tablets Labeling

Avandia (rosiglitazone maleate) Tablets


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.