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10/11/2002

Combination Diabetes Treatment Approved by FDA

Cheryl A. Thompson

Avandamet, a combination product containing rosiglitazone and metformin, was approved for marketing and will be available in pharmacies next month, GlaxoSmithKline announced this morning. The product is indicated, in addition to diet and exercise, for improved control of the blood glucose concentration in patients with type 2 diabetes mellitus who are already taking the two drugs or who are not achieving adequate control with metformin alone.

As with metformin, the contraindications to therapy with the combination product are renal disease or dysfunction, congestive heart failure requiring pharmacotherapy, and metabolic acidosis. A box in the labeling warns about the possibility of lactic acidosis developing in patients during metformin therapy.

The labeling contains instructions on starting combination therapy in patients already receiving one but not both drugs and the explicit direction not to use the product as initial treatment.

Avandamet will be available in tablets containing 1, 2, or 4 mg of rosiglitazone and 500 mg of metformin in 60- and 100-count bottles and unit dose packages.

Rosiglitazone is marketed solely by GlaxoSmithKline under the brand name Avandia. Metformin is available from several companies.