Adverse Drug Reaction Seen With Repaglinide and Gemfibrozil

September 29, 2003

Medscape Staff Report

Sept. 29, 2003 — The U.S. Food and Drug Administration announced today that an adverse drug reaction has been seen during co-administration of repaglinide (Prandin), a short-acting insulin secretagogue, and gemfibrozil (Lopid), a lipid-lowering agent used to treat dyslipidemia.

A study that evaluated the co-administration of gemfibrozil with repaglinide in healthy subjects found a significant increase in repaglinide blood levels. Concomitant use may result in enhanced and prolonged blood glucose-lowering effects of repaglinide. Co-administration of itraconazole (Sporanox), an antifungal, with gemfibrozil and repaglinide further increased such effects.

According to the "Drug-Drug Interactions" section of repaglinide's updated labeling, co-administration of both gemfibrozil and itraconazole with repaglinide resulted in a 19-fold higher repaglinide area under the curve and prolonged repaglinide half-life to 6.1 hours. Plasma repaglinide concentration at 7 hours increased 28.6-fold with gemfibrozil co-administration and 70.4-fold with the gemfibrozil-itraconazole combination.

For patients already receiving repaglinide and gemfibrozil, blood glucose levels should be monitored and repaglinide dose adjustment may be needed, recommended a letter to healthcare professionals from Novo-Nordisk, the maker of Prandin.

Reviewed by Gary D. Vogin, MD

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