Byetta FDA Safety Concerns

Over 700,000 patients have used the drug Byetta since it received FDA approval in 2005. By 2007, however, Byetta FDA warnings were being issued regarding potential dangers of the drug including thyroid cancer, pancreatitis and pancreatic cancer. Thirty adverse reports came in to the FDA between 2005 and 2007, then in the following year six cases of necrotizing pancreatitis were reported as well, with two fatalities among those six Byetta patients.

What is Byetta?

Byetta is a twice-daily injectable drug used in the treatment of Type 2 diabetes. The drug’s active ingredient, exenatide, is a synthetic form of the saliva of the Southwestern Gila monster, and is fifty percent identical to the GLP-1 hormone found naturally in the human digestive tract. GLP-1 works by increasing the body’s insulin in order to balance blood sugar. The synthetic form of this hormone remains effective for a longer period of time than the hormone which occurs naturally in the body. Byetta’s “perk” is that it appears to cause weight loss due to slowing the rate at which the stomach empties—although patients are cautioned against using Byetta as a treatment for obesity.

Byetta FDA Warnings

Byetta FDA warnings came in 2007, 2008 and 2009 as more adverse reports filtered in to the agency. Following thirty reports between 2005 and 2007 of Byetta users who developed pancreatitis—some cases serious enough to require hospitalization—the FDA upped the labeling requirements of Byetta to include a caution to physicians to warn their patients to seek medical assistance should they experience any symptoms of pancreatitis. In 2008—following the six reported cases of necrotizing or hemorrhagic pancreatitis—Byetta thyroid cancer FDA safety concerns amplified. The four living patients were taken off Byetta and Amylin, along with partner Eli Lilly, was ordered to add labeling warnings to patients to discontinue Byetta and see their physician if they experienced any symptoms of pancreatitis. Further, any patients receiving a diagnosis of pancreatitis were instructed to consider another drug to treat their Type 2 diabetes.

Potential Byetta Dangers

By 2009, 78 reports of renal issues had been reported to the FDA from Byetta patients and the labeling was once more changed to reflect more specific information regarding accounts of kidney issues among Byetta users. This series of labeling revisions were meant to allow doctors to make a more comprehensive risk vs. benefit assessment for their patients with Type 2 diabetes prior to prescribing Byetta. The FDA is currently taking a harder look at all those diabetes medicines which belong to a class of drugs known as incretin mimetics. Byetta falls within this class of drugs, and while a Byetta thyroid cancer potential recall is not yet on the horizon, those taking the drug should be aware of the potential dangers. Recent studies point to a two-fold increase in the incidence of thyroid cancer, a three-fold increase in the incidence of pancreatic cancer and a six-fold increase in the incidence of pancreatitis among those taking Byetta. 

Byetta Thyroid Cancer Legal Action

If you or a loved one suffered harm as a result of taking Byetta, it could be beneficial to consult with an experienced Byetta Attorney. You may be entitled to equitable compensation for medical expenses, pain and suffering and lost wages.