(2003; 14 pages)
REPAGLINIDE - Contraindicated with gemfibrozil
Europe. The European Medicinal Products Evaluation Agency (EMEA) has issued a public statement about an interaction between repaglinide (Novonorm/Prandin), a medicine used to lower blood sugar in diabetic patients, and gemfibrozil, a lipid- lowering agent. The blood glucose lowering effect of repaglinide maybe markedly enhanced and prolonged when administered together with gemfibrozil, with an increased risk of severe hypoglycaemia. The Agency has received 5 reports of serious adverse hypoglycaemic episodes in patients using repaglinide and gemfibrozil at the same time. Therefore, the EMEA’s Committee for Proprietary Medicinal Products (CPMP) has decided to contraindicate the concomitant use of these two drugs. Patients already receiving repaglinide and gemfibrozil should be reviewed and put under alternative combination treatment with close monitoring of diabetic status. The repaglinide Summary of Product Characteristics (SPC) and the product package leaflet have been appropriately modified to reflect the above mentioned contraindication.
EMEA Public Statement (EMEA/11700/03), 21 May 2003. Available from URL: http://www.emea.eu.int