Byetta FDA Warnings

byetta fda

Amylin Pharmaceuticals, manufacturer of Byetta—a drug used in the treatment of type 2 diabetes—has come under scrutiny as more and more consumers come forward to report serious side effects from the drug. Pancreatitis and pancreatic cancer as well as thyroid cancer appear to be potential risks consumers face when taking Byetta. The manufacturers of the drug, Amylin and Eli Lilly, were partners in the development and sales of the drug, however in 2011 the two pharmaceutical giants split; Amylin was given “custody” of Byetta although the agreement gave Lilly a portion of all future Byetta sales. In 2012, Amylin Pharmaceuticals sold to Bristol-Myers Squib for $5.3 billion.

Aside from pancreatic issues related to Byetta, a study published by Dr. Peter Butler in the journal Gastroenterology appeared to establish a link between Byetta and the onset of thyroid cancer. Further, the GI & Hepatology News—the official newspaper of the AGA—stated the risk of thyroid cancer was significantly elevated among those taking exenatide, putting the odds ratio at 4.7 times the rate for a person not taking the drug. Dr. Butler states that while the analysis of the FDA database does not definitively establish that thyroid cancer, pancreatic cancer and pancreatitis are caused by Byetta or other forms of GLP-1 therapy, it does “raise the level of concern that they may be and that the appropriate prospective studies are required to rule them out.”

The Byetta FDA Stance has changed somewhat through the years. Byetta first gained FDA approval on April 28, 2005 then in October, 2007, the first Byetta FDA notice regarding the drug was issued. This first warning notice came after the FDA reviewed 30 post-market accounts of acute pancreatitis among Byetta patients. Among the 30 patients diagnosed with acute pancreatitis, six experienced symptoms of pancreatitis soon after their dosage of Byetta was increased.

Twenty-one of the thirty were hospitalized with five developing serious complications. Twenty-two of the 30 patients improved when Byetta was discontinued with nausea and vomiting re-occurring in two patients once Byetta was restarted. In the first notice the FDA cautioned healthcare professionals to instruct those taking Byetta to see their doctor should they experience any symptoms of pancreatitis such as serious abdominal pain which doesn’t stop and has no other explanation. The FDA also ordered Amylin to clearly include data regarding acute pancreatitis on the drug’s label.

The second FDA Byetta pancreatitis update occurred in August, 2008 in which the FDA noted receipt of six cases of hemorrhagic or necrotizing pancreatitis among patients taking Byetta. All six patients were admitted to the hospital for their symptoms; there were two fatalities and at the time the report was issued the remaining four were recovering. The four patients who survived were taken off Byetta. The FDA cautioned those who were experiencing any symptoms of pancreatitis to discontinue the drug and make an appointment with their physician immediately. Further, the FDA noted that once a diagnosis of pancreatitis is made, those taking Byetta should discontinue the drug and another anti-diabetic therapy should be considered. Once again, the FDA directed Amylin to include clearer more conspicuous warnings on the label concerning the risk of acute hemorrhagic or necrotizing pancreatitis.

In November, 2009, the FDA once again sanctioned changes to Byetta’s labeling to include the specific information on accounts of altered function of kidneys, acute renal failure and insufficiency. From April, 2005 through October, 2008, seventy-eight cases of renal issues were reported to the FDA among those using Byetta. During that time frame over six and a half million prescriptions for Byetta were distributed. These revisions to the labeling of the drug were meant to make it possible for doctors to conduct a risk vs. benefit assessment prior to prescribing Byetta. The third round of labeling revisions also included the statement that Byetta should not be used in patients with impaired kidney function, that physicians should exercise caution when increasing the dosage of Byetta in those with moderate renal impairment, and that physicians should closely monitor their patients for any signs of kidney dysfunction.

Those with diabetes are approximately three times more likely to develop pancreatitis than the general population, and certain diabetic medications such as Byetta increase this risk even further. In 2009, the FDA required Amylin Pharmaceuticals to conduct six post-marketing surveillance studies to investigate the risks of pancreatic cancer and thyroid cancer among those taking Byetta. This requirement was made because of the more than 100 reports of thyroid and pancreatic cancer among Byetta patients prior to 2009.

A recent study reported by Bloomberg linked Byetta to double the risk of pancreatitis which could change the way doctors treat the more than 25 million Americans with type 2 diabetes. This study was published on February 25, 2013 in the JAMA Internal Medicine Journal and noted that pancreatic lesions from Byetta could lead to inflammation of the pancreas, pancreatitis and pancreatic cancer. Those who have suffered harm from taking the drug Byetta may have a case and could be eligible for reimbursement of medical expenses, lost wages, both past and future and pain and suffering. Contact he attorneys of Sullo & Sullo for a free legal consultation. They can offer you compassion for your injuries while providing zealous legal representation.

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