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Prandin FDA Alerts

The FDA Alert(s) below may be specifically about Prandin or relate to a group or class of drugs which include Prandin (repaglinide).

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for repaglinide

Prandin (repaglinide)

Sep 29, 2003

Audience: Endocrinologists, pharmacists and other healthcare providers

Novo Nordisk and FDA revised the PRECAUTIONS/Drug Interaction section of the prescribing information to inform healthcare professionals of a drug-drug interaction between 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 PRANDIN 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. For patients already on PRANDIN and gemfibrozil, blood glucose levels should be monitored and PRANDIN dose adjustment may be needed.

[Sept, 2003 Letter - Novo Nordisk] PDF Format
[August, 2003 Revised, highlighted label - Novo Nordisk] PDF Format

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