FDA adds kidney health warnings to Byetta label

After new approval, FDA adds warnings to label of Lilly and Amylin's diabetes drug Byetta

• On 5:21 pm EST, Monday November 2, 2009

NEW YORK (AP) -- The Food and Drug Administration approved new warnings for the diabetes drug Byetta Monday, adding cautions about links between Byetta and kidney problems.

The revised Byetta label says that Byetta should not be used by patients with kidney disease or risk factors for kidney disease because they may suffer impaired function or kidney failure. Byetta, or exenatide, is made by Amylin Pharmaceuticals Inc. and sold by Eli Lilly & Co.

The new label includes information about reports of kidney failure and insufficiency and says Byetta should not be used by patients with end-stage kidney disease or several kidney impairment. It suggests health care workers be cautious about starting patients on Byetta or increasing their doses if the patients have moderate kidney problems, or if they have had a kidney transplant.

The most common side effects included nausea, vomiting and diarrhea, and those may have contributed to the reported kidney trouble.

"Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems," said Amy Egan of the FDA's Center for Drug Evaluation and Research.

On Friday, the FDA approved marketing of Byetta as a standalone drug that can be used to control blood sugar in type 2 diabetes patients. Byetta was approved in 2005, but the FDA only allowed the companies to market it to patients who were using other medicines but could not get good enough control of their blood sugar levels.

The FDA said it based the new warnings on reports of problems from patients. Between April 2005 and October 2008, the FDA received 78 such reports. About 6.6 million Byetta prescriptions were filled over that time, the agency said.

Worldwide Byetta sales totaled $205.7 million in the third quarter. The two companies share revenue from U.S. sales, and Lilly gets all the revenue from international sales.

Eli Lilly is based in Indianapolis and Amylin is headquartered in San Diego. Amylin shares rose $1.09, or 9.9 percent, to $12.13 on Monday, while Lilly stock gained 4 cents to $34.05.

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