American Diabetes Month: New warning on Byetta

November 2, 11:58 PMSF Senior Care ExaminerLiz Macera

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Healthcare practitioner reviewing instructions with patient

National Institutes of Health

The Food and Drug Administration (FDA) issued new guidelines on Byetta® (exenatide) for health professionals on Monday. FDA revised the prescribing information for health professionals and made suggestions for teaching people taking exenatide about possible side effects, including kidney disease.

The new guidelines utilize information from post-marketing reports on the possibility of impaired kidney function, including acute renal failure and insufficiency. Byetta® is an incretin-mimetic approved by the FDA for use in adults with type 2 diabetes mellitus. It enhances the effects of good nutrition and exercise on blood sugar control. From April 2005 through October 2008, FDA received 78 reports of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta®.

Information for people taking Byetta® should include explanations of kidney disease and the benefits and potential risks associated with Byetta®. Pay close attention to changes, such as differences in urine (color, frequency, amount), unexplained swelling in the arms or legs, changes in blood pressure, feeling unusually tired, changes in appetite or digestion, or a dull ache in mid to lower back. Vomiting and diarrhea can lead to dehydration, which can make your kidneys more vulnerable to damage, so call your health care professional if these occur while you are on Byetta®.

Labeling changes for health professionals include post-market reports of acute renal failure and insufficiency. The new FDA report emphasizes that Byetta® should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease. Health professionals should carefully monitor patients when increasing the dose from 5 mcg to 10 mcg in people with moderate renal impairment (creatinine clearance 30 to 50 ml/min).

Safety studies are done on all medications prior to approval, but clinical trials involved a limited number of patients. Adverse effects (side effect or any bad result) that are rare many not be seen until thousands of people take the medication. This only happens when a medication is released for general use.

Contact your prescriber if you are on Byetta® and have additional questions about how this news affects you. Do not stop or change the dose of your medication without talking with your healthcare provider.

The information for this article is from an FDA press release.
This article is for educational purposes only and is not personal medical advice.

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