FDA Issues Warning for Diabetes Drug
TUESDAY Nov. 3, 2009 -- Reports about possible kidney problems, including renal failure, in people taking the diabetes drug exenatide (Byetta) have prompted changes to the drug's prescribing information, the U.S. Food and Drug Administration said Monday.
From April 2005 to October 2008, the FDA received 78 reports of kidney function problems in patients taking Byetta. Most of the problems occurred in patients with pre-existing kidney disease or one or more risk factors for developing kidney problems. Byetta is prescribed for type 2 diabetes; 7 million prescriptions were filled between April 2005 and September 2008, according to the agency.
"Health-care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research, said in an FDA news release.
"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 the mid- to lower back," Egan said.
She advised patients with any of these symptoms to immediately consult with a health-care professional.
Byetta, made by San Diego-based Amylin Pharmaceuticals Inc., is used to control blood sugar levels.
Nausea, vomiting and diarrhea are the most common side effects associated with the drug. These side effects may contribute to the development of kidney malfunction, which can lead to a build-up of waste products in the blood, resulting in serious illness and potentially life-threatening conditions.
The American Academy of Family Physicians has more about kidney failure.
Posted: November 2009