November 2, 2009: FDA Issues Safety Alert for Byetta
The FDA announced today that a labeling change has been made for Byetta (exenatide).
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 safety alert warns medical professionals that kidney problems may occur if used under certain conditions. These conditions include having prior risk factors that range from hypertension to urinary tract infection.
To date, there have been 78 reported cases of patients having either renal failure or renal insufficiency.
Adverse events that occur with the use of Byetta should be reported to the FDA’s MedWatch Adverse Event Reporting Program as follows:
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