FDA Drug Safety Communication

FDA has approved revisions to the drug label for Byetta (exenatide) to include information on postmarketing reports of altered kidney function, including acute renal failure and insufficiency. The revisions to the drug label include:

- Information regarding postmarket reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/min) or end-stage renal disease.

- Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min).

- Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.

- Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov