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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