Issue 157 Item 4 Warning Against Concomitant Use of Repaglinide and Gemfibrozil

European drug regulators warned on Wednesday that Novo Nordisk’s oral antidiabetic Prandin/NovoNorm (repaglinide) can cause severe hypoglycemia if patients take the lipid-lowering agent gemfibrozil at the same time. In a statement, the European Medicines Evaluation Agency said a recent study shows that the blood glucose lowering effect of repaglinide could be “markedly enhanced and prolonged when taken with gemfibrozil.

“In addition, five reports of hypoglycemic episodes in patients using repaglinide and gemfibrozil at the same time have been received.”

The agency said concomitant use of the two products is contraindicated. It advises that patients receiving repaglinide and gemfibrozil contact their doctor who should consider alternative combination treatments.

Researchers in Helsinki warned last year that gemfibrozil, a non-proprietary inhibitor of the CYP2C8 liver enzyme, greatly increased serum concentrations of cerivastatin, which might partly explain the high incidence of rhabdomyolysis that triggered the withdrawal of Bayer’s statin.

Repaglinide, which stimulates insulin secretion, is indicated as monotherapy or in combination with metformin, rosiglitazone or pioglitazone in patients with type 2 diabetes.

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