Byetta Kidney Problems Result in New FDA Warning

By Austin Kirk
Posted November 3, 2009

ADD YOUR COMMENTS 3

The FDA issued a new warning Monday about the potential risk of Byetta kidney problems, indicating that nearly 80 patients have developed kidney insufficiency or kidney failure, which can result in serious illness or death. The lawyers at Saiontz & Kirk, P.A. currently represent individuals who have a potential Byetta lawsuit for pancreatitis as a side effect of the drug. The possibilities of Byetta kidney lawsuits are now being reviewed and evaluated.

>>FDA LINK: Byetta Kidney Problem Warning

Bytta (exenatide) is a popular type-2 diabetes drug made by Amylin Pharmaceuticals, Inc. and Eli Lilly & Co. First approved by the FDA in April 2005, nearly 7 million prescriptions have been dispensed since September 2008. Although only a small number of users have reported kidney problems on Byetta, the FDA is cautioning doctors and patients to be aware of the risk of problems with kidney function.

The FDA reports that 78 patients have reported problems with kidney function with Byetta, including at least 62 cases of Byetta kidney failure, which can cause waste products to build up in the blood, potentially resulting in severe injury or death. The FDA indicates that common Byetta side effects, which include nausea, vomiting and diarrhea, may have contributed to the development of kidney problems in users.

According to a press release issued on November 2, 2009, users should be aware of the potential risk of Byetta kidney problems and watch for symptoms, such as:

• Nausea, Vomiting and Diarrhea
• Changes in urine color and frequency of urination
• Fatigue
• Swelling of hands or feet
• Changes in appetite or digestion
• Dull aches in the mid to lower back

The FDA indicates that revisions are being made to the prescription information for Byetta (exenatide) regarding the reports of kidney problems. In addition, a patient Medication Guide is being required to ensure that users understand that benefits and potential risks of Byetta. Labeling changes include:

• Information will be added about post-marketing reports of renal insufficiency and acute renal failure on Byetta, highlighting that the drug should not be used in patients with severe kidney impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
• Recommendations that doctors exercise caution when starting or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate kidney problems (creatinine clearance 30 to 50 ml/min).
• Recommendations that doctors monitor patients for the development of kidney dysfunction on Byetta, and evaluate the continued need for the drug if Byetta kidney problems are suspected.

BYETTA KIDNEY FAILURE LAWSUIT LAWYERS

The product liability lawyers at Saiontz & Kirk, P.A. first began evaluating the possibility for Byetta lawsuits in October 2007, when the FDA issued an alert about reports of several dozen users who developed pancreatitis on Byetta. In August 2008, the FDA issued another warning about additional reports of severe cases of hemorrhagic pancreatitis and necrotizing pancreatitis, including several deaths.

Following these latest warnings, we are now examining the potential for Byetta kidney failure lawsuit claims. If you, a friend or family member have been diagnosed with kidney problems, such as impared kidney function, dialysis or kidney failure on Byetta, submit information about your potential claim for review by our attorneys by requesting a free consultation and claim evaluation.