Jane S. Ricciuti, RPh, MS

Disclosures

April 22, 2003

In This Article

Antidiabetic Agents

Avandia
(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

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