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Byetta aka Exenatide: Reports from diabetics of kidney problems & renal failure prompt new warnings from U.S. Food and Drug Administration on diabetes drug.

The U.S. Food and Drug Administration (FDA) has approved new language to be included on the drug label of popular diabetes medication Byetta, also known as exenatide. The new language will include information on reports of altered kidney function, including acute renal failure, after diabetic patients began using the drug.

The FDA fielded a total of 78 complaints from diabetics taking the drug between April 2005 and October 2008. These complaints included 78 cases of altered kidney function, 62 cases of acute renal failure and 16 cases of renal insufficiency. During this same time period, 6.6 million prescriptions for the diabetes treatment Byetta were written.

Side-effects of Byetta reported to the FDA included nausea, vomiting, and diarrhea. These were also the most common side effects experienced with Byetta during clinical trials. It is unknown at present if the side effects may have contributed to the development of altered kidney function and acute renal failure.

San Diego-based Amylin Pharmaceuticals Inc., manufacturer of Byetta, will be forced to include several pieces of additional information on their labels as a result of the FDA’s actions. Some of the new information being made to diabetics and their physicians include:

• Reports of acute renal failure and kidney insufficiency. Byetta should not be used in patients with severe renal impairment or end-stage renal disease.

• Recommendations to Doctors that caution should be applied when starting or increasing dosages of Byetta from 5 mcg to 10 mcg in patients that suffer from moderate renal impairment.

• Recommendations that physicians monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.

• Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Another FDA Warning on Byetta For Diabetics

In 2007, the U.S. Food and Drug Administration first issued a warning to diabetic patients using Byetta, due to the fact that cases of Acute Pancreatitis had been reported with its use. The FDA stated that six cases of hemorrhagic pancreatitis had been reported, and that two of those cases had been fatal.

Below is a Yotube video made by the FDA in 2008, detailing its warnings about Byetta possibly causing pancreatitis in diabetes patients.

In August 2008, Bloomberg Television aired a report on how investors were turning cautious on Amylin after a conference call revealed six deaths linked to the Eli Lilly co-marketed diabetes drug. YouTube video from the story is available below: