FDA Requires Additional Byetta Studies After Reports Of Kidney Failure, Pancreatitis & More

The U.S. Food & Drug Administration (FDA) is requiring Eli Lilly and Amylin Pharmaceuticals to perform additional safety studies on its type 2 diabetes drug, Byetta (exenatide). The studies are needed to assess the drug's risk of acute renal (kidney) failure, thyroid cancer and pancreatitis and were prompted by Amylin's August 2008 announcement that six patients had died from hemorrhagic or necrotizing pancreatitis after taking the drug.

Ongoing Byetta controversy

Approved by the FDA in 2005 to help diabetics control type 2 diabetes when other medications didn't, the controversy over Byetta continues five years later. Requiring a twice-daily injection, Byetta is a synthetic form of a hormone derived from lizards which boosts the body's production of insulin to control blood sugar levels. While it was just approved as a stand-alone therapy for type 2 diabetes in October of 2008, injuries and deaths reported due to Byetta use have been ongoing since it was first approved – which prompted the additional study requirements.

FDA study requirements

According to Reuters, the FDA is requiring Lilly and Amylin to conduct these studies:

• An epidemiological study on acute pancreatitis in Byetta versus non-Byetta patients
• Eidemiologic queries on pancreatic cancer and thyroid neoplasm in Byetta versus patients taking certain alternative therapies
• A clinical trial to see whether Byetta may increase the risk of gallstones, and therefore pancreatitis

These new requirements follow FDA warning letters to Lilly and Amylin in 2008 concerning label changes for Byetta.

News of the most recently required studies was discovered accidentally by a financial analyst who came across a file containing those requirements – something the company did not want released as its stock has since plunged.

Byetta product liability lawsuits

Byetta lawyers say that the manufacturers failed to adequately test the drug before it was released into the marketplace and that patients now have an increased risk of serious Byetta side effects such as hemorrhagic or necrotizing pancreatitis (which may lead to kidney failure) and may include side effects such as abdominal / back pain; abnormally foul smelling, pale, oily feces; bruising of the lower back and/or navel, fever, nausea and vomiting. Numerous product liability lawsuits have been filed against the manufacturers.

The foregoing article has been prepared by an attorney who is a regular contributor to FreeAdvice, and is now undergoing review by the site's editorial staff.