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FDA changes prescribing information on popular diabetes mellitus treatment
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Type 2 diabetics who have kidney disease may be at additional risk if they take Byetta.
November 2 - Some treatment plans for type 2 diabetes may need to be modified, as the FDA has prompted prescribing information changes for the popular drug Byetta. According to the FDA, from April 2005 until October 2008, 78 reports of impaired kidney function was reported. For type 2 diabetes, (non insulin type of diabetes) Byetta is a popular option with over 7 million prescriptions during that period of time. It is important to note however, that the majority of those reporting kidney issues occurred in patients that already had pre-existing kidney disease or significant risk factors. The revised Byetta label now says that it should not be used by patients with kidney disease or risk factors for kidney disease. This revised labeling occurs within days of the FDA approving the marketing of Byetta as a stand alone drug. Byetta was approved in 2005, but the FDA only allowed it to be marketed to patients who were already using other medicines but could not get good enough control of their blood sugar levels.
What Byetta is
Byetta is made by San Diego-based Amylin Pharmaceuticals Inc. and is sold by Eli Lilly & Co. It is used to control blood sugar levels in patients with type 2 diabetes.
How Byetta may cause injury
Nausea, vomiting and diarrhea are the most common side effects associated with the drug. These conditions can lead to dehydration. Dehydration may contribute to the development of kidney disease. This can lead to a build-up of toxins and electrolyte imbalanced in the blood, resulting in potentially life-threatening conditions.
Physician Responsibility
Physicians need to be on the lookout for renal (kidney) issues with type 2 diabetes patients taking Byetta. This would be especially true if any of these patients already had compromised kidneys. Dr. Amy Egan, of the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research said "Health-care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems."
Patient Responsibility
Patients need to be aware of the signs of kidney problems. "Patients 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.
DO NOT stop taking any of your prescribed medications without first talking to your doctor. Be aware of the potential of side effects and kidney disease with Byetta, and notify your healthcare provider if you have symptoms..
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