Byetta

Byetta (manufactured by Amylin Pharmaceuticals and Eli Lilly) is an injectable prescription medicine approved in April of 2005 for the treatment of Type-2 diabetes. Approximately 700,000 patients in the United States have used this medication to help control blood sugar levels. Recently, the Byetta (exenatide) has been linked to serious cases of kidney problems, pancreatitis, renal failure, and even death.

How Does Byetta Work?

According to the drug manufacturers, Byetta actually helps your body make more of its own insulin, especially after meals. Byetta helps to slows down the rate at which glucose enters the bloodstream, and the drug signals the pancreas to make the right amount of insulin at the right time to help blood glucose remain closer to normal. After blood glucose levels off, Byetta stops signaling the pancreas to produce insulin. This effect helps the body avoid low blood glucose, too (called hypoglycemia). As a result, Byetta may help reduce your high blood glucose levels throughout the day. And that can mean better control, which can be one of the keys to helping manage your diabetes.

FDA Warnings

The warnings about this medication began in October of 2007 when the FDA issued an alert about a possible link between Byetta and 30 reported cases of pancreatitis. Less than a year later in August of 2008, the FDA issued a MedWatch alert to medical providers about a suspected association between Byetta and several patients who developed a more-severe necrotizing pancreatitis and hemorrhagic pancreatitis resulting in at least two patient deaths. The FDA urged doctors to carefully monitor their patients for any symptoms of suspected pancreatitis, usually in the form of severe abdominal pain.

Additional Byetta Warnings Mount

In March 2009, reports of kidney-related side effects in patients in the United Kingdom were detailed in the Drug Safety Update Newsletter. The European report indicated that there had been six cases of pancreatitis and an additional three cases of acute pancreatitis reported in the U.K. as of February 2009. Further, the report said that 396 reported cases of pancreatitis involving Byetta had been received worldwide as of September of 2008 (mostly in the United States).

In October of 2009, the Amylin Pharmaceuticals and Eli Lilly issued a "Dear Doctor" letter revealing post-marketing data showing patients developed Byetta-induced acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis and urging doctors to discontinue Byetta immediately if pancreatitis is suspected in any patient. On November 2, 2009, the FDA issued a release that the Byetta's warnings had been revised to include information about numerous post-marketing reports of patients developing serious kidney problems, including acute renal failure and insufficiency. In the Information for Healthcare Professionals release, the FDA indicated that there had been 78 cases reported to the FDA's Adverse Event Reporting System relating to altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency) from April 2005 through October 2008.

If you or someone you love have developed kidney problems, pancreatitis, renal failure and took Byetta, please contact the experienced pharmaceutical trial attorneys at Alley, Clark & Greiwe for important information about your legal rights.