EMEA public statement on Replaglinide (NovoNorm/Prandin) contraindication of concomitant use of Replaglinide and Gemfibrozil
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The EMEA wishes to inform the public about an interaction between repaglinide, a medicine used to lower blood sugar in diabetic patients, and gemfibrozil, a lipid-lowering agent.
A recent scientific publication1 indicates that the blood glucose-lowering effect of repaglinide may be markedly enhanced and prolonged when administered together with gemfibrozil, with an increased risk of severe hypoglycaemia. In addition, 5 reports of serious hypoglycaemic episodes in patients using repaglinide and gemfibrozil at the same time have been received. The Agency's Committee for Proprietary Medicinal Products (CPMP) has therefore decided to contraindicate the concomitant use of repaglinide and gemfibrozil.
There are two repaglinide products authorised in the European Union, NovoNorm and Prandin, authorised in August 1998 and January 2001 respectively. The Marketing Authorisation Holder for both products is Novo Nordisk.
Repaglinide is indicated in patients with Type 2 diabetes (Non Insulin Dependent Diabetes Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in Type 2diabetes patients who are not satisfactorily controlled on metformin alone. Repaglinide is currently marketed in all EU Member States (except Portugal), Norway and Iceland.
The EMEA wishes to point out the following important safety information to physicians:
- In view of a documented interaction and risk of hypoglycaemia, the concomitant use of repaglinide and gemfibrozil is contraindicated.
- Patients already receiving repaglinide with gemfibrozil should be reviewed and alternative combination treatment considered under close monitoring of diabetic status.
Information for patients taking repaglinide:
• If you are on repaglinide (NovoNorm, Prandin) for diabetes and are also given gemfibrozil you may be at risk of severe or prolonged hypoglycaemia (low blood sugar). You should therefore contact your doctor as you may require adjustment in your medication.
As an urgent measure, the prescribing and patient information of repaglinide have been modified through a rapid procedure at the request of the Marketing Authorisation Holder. Relevant changes to the product information are indicated below. The complete revised product information is available in the European Public Assessment Report of NovoNorm and Prandin published on the EMEA Website.