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Back To Vidyya FDA Approves Glucovance For Type II Diabetes

Drug May Be Used As First Or Second-Line Therapy

Bristol-Myers Squibb Company announced on 02-August-2000 that it has received approval from the US Food and Drug Administration (FDA) to market Glucovance. The drug may be used as an initial drug therapy for patients with type II diabetes, in conjunction with diet and exercise, or as second-line therapy when diet, exercise and initial treatment with a sulfonylurea or metformin do not result in adequate glycemic control in patients with type 2 diabetes.

Glucovance, a combination of the widely prescribed antidiabetic drugs glyburide and Glucophage, was approved in 1.25 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths.

Glucovance will be available to pharmacies and physicians within the next week.

In rare cases, the drug may cause lactic acidosis, which is potentially fatal in up to half of all cases. The disorder occurs mainly in patients whose kidneys are not functioning properly. Glucovance is contraindicated in patients with kidney problems, people 80 years of age or older unless they first undergo kidney testing, patients taking heart-failure medication and those with a history of liver disease or who drink alcohol excessively.

The drug's most common side effects are diarrhea, nausea and upset stomach and, to a lesser extent, hypoglycemia, which can cause dizziness, shakiness or increased appetite.

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Editor: Susan K. Boyer, RN
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