Antidiabetic AgentsAvandia (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.
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: April 2003 - Medscape - Apr 23, 2003.