New Safety Warnings About Diabetes Drug and Kidney Functions

Recently, the safety warnings were strengthened for the diabetes drug Byetta relating to the risks of pancreatitis and the medicine’s use by patients with severe kidney disease. Specifically, the US Food and Drug Administration (“FDA”) notified healthcare professionals of revisions to the prescribing information for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency.

The increased warnings come after six patients taking Byetta died in August 2008 from pancreatitis, an inflamed pancreas. Furthermore, from April 2005 through October 2008, the FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Overall, 91 percent of patients were hospitalized, 18 required dialysis, two had kidney transplants, and four died. Eighty percent stopped taking Byetta, and half of those patients had an improvement in kidney function after stopping the drug.

It is now advised that patients with “severe kidney problems” should not take Byetta and that any treatment with Byetta should be done “with caution” in people who have had a kidney transplant.

Byetta, manufactured by Amylin Pharmaceuticals and Eli Lilly, is approved for use as a supplement to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Byetta is administered via twice-daily injection and has been sold since April 2005 for patients also taking other diabetes medications. Doctors wrote almost 7 million Byetta prescriptions between 2005 and 2008 with a main consideration being that it’s easier to inject than insulin and can promote weight loss in some people.

If you have any questions related to this information, please contact us at Pogust Braslow & Millrood. Additionally, as with any medication, side-effects related to this drug should be reported to the FDA.