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November 2, 2009: FDA Issues Byetta Safety Alert

Byetta Safety Alert – The Food and Drug Administration (FDA) notified healthcare professionals today of revisions to the Byetta label to include information on reports of altered kidney function, including acute renal failure and insufficiency.

Byetta is an injectable prescription drug. It is used to control the level of glucose in the blood for patients with type 2 diabetes. The drug is made by Amylin Pharmaceuticals Inc., which is based in San Diego, California.

The FDA stated that from April 2005 through October 2008, it received 78 reports of renal failure (62 cases) or renal insufficiency (16 cases) in patients using Byetta. Some of these patients had pre-existing kidney disease, or one or more risk factors for developing kidney problems.

Byetta Safety Alert and Labeling Revisions

Please see FDA Byetta Label Revisions for a complete description of the labeling changes.

Consumers and healthcare professionals can report drug side effects to the FDA’s safety and adverse event reporting program at MedWatch.

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