FDA Warns Of Byetta's Link To Kidney Failure

The U.S. Food & Drug Administration (FDA) has warned doctors and patients about links to Eli Lilly and Amylin Pharmaceuticals' diabetic drug Byetta (exenatide) and renal failure and is requiring the manufacturers to change the drug's labeling.

FDA warning letters

The FDA has sent warning letters to Byetta patients and doctors informing them that it has received 62 cases of kidney failure and 16 cases of kidney insufficiency in patients taking Byetta – an injectable medicine used to improve glucose (blood sugar) control in adults with type 2 diabetes – from April 2005 to October 2008. Seventy-one of the 78 cases required hospitalization and four Byetta deaths have been reported. The most recent FDA warning communication requires Lilly and Amylin to make the following label changes and include:

• Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <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.

Byetta side effects

Byetta attorneys say that the drug's increased risk of hemorrhagic or necrotizing pancreatitis (which may lead to kidney failure) may include side effects include abdominal / back pain; abnormally foul smelling, pale, oily feces; bruising of the lower back and/or navel, fever, nausea and vomiting.

Many consumer advocate groups and Byetta lawyers say that the FDA should require Byetta to carry a black box warning, but so far, the Administration has not done so. Lawsuits filed against the manufacturers allege that Byetta is a defective product, was rushed to market and was inadequately tested prior to market release.