Byetta is a drug used in the treatment of Type 2 diabetes, administered twice daily in the form of an injection. The drug is taken within one hour prior to eating breakfast and dinner; while marketed vigorously as a drug which can improve blood sugar levels as soon as day one as well as a “chance to lose some weight,” potential Byetta dangers have since come to light. Several studies show a link between Byetta use and thyroid cancer, pancreatitis and pancreatic cancer.
Byetta FDA Stance
Between the time Byetta was approved by the FDA in 2005 and 2007, 30 adverse reports came in to the FDA from Byetta users who had developed pancreatitis serious enough to land many of them in the hospital. When Byetta was discontinued, the majority saw an immediate reduction in their pancreatitis symptoms. By 2008 six more adverse reports came to the FDA’s attention-two of those died from their acute pancreatitis symptoms. Byetta FDA warnings began in October, 2007 when a Byetta FDA notice was issued. This first notice cautioned doctors to warn their patients to see a doctor should they experience any pancreatitis symptoms after taking Byetta.
Such symptoms could include serious abdominal pain which radiates to the back, doesn’t stop and has no other explanation. Amylin Pharmaceuticals and Eli Lilly—co-manufacturers of Byetta—were ordered to include data on the labeling of Byetta which clearly states information regarding pancreatitis. Following the second six cases of hemorrhagic or necrotizing pancreatitis, the Byetta FDA safety concerns increased; the four patients who survived were taken off Byetta and the FDA once again cautioned those experiencing any potential pancreatitis symptoms to discontinue the drug and see their physician immediately. Following a definitive diagnosis of pancreatitis, the FDA further cautioned those taking Byetta to consider another diabetic drug therapy.
Amylin and Eli Lilly were ordered yet again to include more conspicuous warnings on the Byetta labels detailing the risks of necrotizing or hemorrhagic pancreatitis. By November, 2009, more labeling changes were given by the FDA which instructed Amylin to include specific information regarding accounts of altered kidney function, acute renal failure and renal insufficiency among patients taking Byetta. Between April, 2005 and October, 2008, nearly 80 cases of renal issues were reported to the FDA from Byetta users. In that three and a half year period over six and a half million prescriptions for Byetta were distributed. The labeling revisions were intended to help doctors make a risk vs. benefit assessment before prescribing Byetta to their patients. Currently the FDA is looking at all medications belonging to a class of drugs known as incretin mimetics—including Byetta.
Byetta Thyroid Cancer Legal Help
Those who have suffered injury after beginning Byetta could have a Byetta thyroid cancer lawsuit and be eligible for reimbursement of doctor and hospital bills, lost wages and even pain and suffering. A qualified Byetta attorney should have a thorough understanding of the entire process of a product liability case, and be able to provide you with a comprehensive evaluation of your specific Byetta thyroid cancer case.