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Drug Interaction Warning Issued for Repaglinide, Gemfibrozil

ROCKVILLE, MD - September 30, 2003 - A drug-drug interaction between repaglinide (PRANDIN), a short-acting insulin secretagogue, and gemfibrozil (Lopid) a lipid-lowering agent used to treat dyslipidemia, was recently reported in a publication by Niemi et al.

The results of this study indicate that co-administration of gemfibrozil with PRANDIN in healthy volunteers resulted in a significant increase in repaglinide blood levels. Co-administration of itraconazole, an antifungal, with gemfibrozil and PRANDIN further increased such effects. Itraconazole in combination with PRANDIN exhibited less pronounced effects than gemfibrozil.

Changes in repaglinide pharmacokinetics were attributed to inhibition of the cytochrome P-450 enzyme system by gemfibrozil and itraconazole. Changes in the blood glucose concentration were also affected by these concomitant medications, with enhanced and prolonged pharmacodynamic effects of repaglinide. While the study was done in healthy volunteers, Novo Nordisk considers these results to be important, as an increased risk of hypoglycemia cannot be ruled out for patients with type 2 diabetes. Based upon what is currently known of the metabolism of other lipid-lowering fibrate derivates, a similar interaction between PRANDIN and other agents within the class is not expected.

Through this announcement, Novo Nordisk is informing all general practice and family practice physicians, internists, endocrinologists, and retail and hospital pharmacies of a change in the PRANDIN package insert regarding this drug interaction. Affected sections are shown on the following page. The new text is underlined.

If you require further information, please contact our Drug Information Department at 1-800-727-6500.

Source: The Food and Drug Administration

View the entire warning letter here: https://www.fda.gov/medwatch/SAFETY/2003/prandin_deardoc.pdf

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