In October 2007 and August 2008, the U.S. Food & Drug Administration (FDA) issued Healthcare Alerts linking approximately 30 cases of acute pancreatitis in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes. Byetta is manufactured by San Diego-based Amylin Pharmaceuticals Inc.
The FDA told healthcare professionals to advise patients taking Byetta to seek emergency medical services if they begin to experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting which could be a sign of acute pancreatitis. The FDA also requested that Amylin Pharmaceuticals, Inc. add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.
On Nov. 2, 2009, the FDA issued a news release that the label for Byetta was revised to include safety information on possible kidney problems.
The FDA acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta. According to the FDA report, from April 2005 through October 2008, they received 78 reports of problems with kidney function in patients using Byetta. The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.
“Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,” said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research. “Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.” Patients who experience any of these symptoms should immediately discuss them with their doctor.
If you or a loved one were taking Byetta and were diagnosed with pancreatitis or kidney problems, call us toll-free at (800) 351-8588 for a free legal consultation. You may also click here to send us your contact information and have a representative from our office get in touch with you.