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FAQ / InfoByetta Pancreatic Cancer, Byetta Thyroid Cancer FAQ
What is Byetta used for?Byetta, known generically as exenatide, is used as a treatment to improve glycemic control in adults who have type 2 diabetes mellitus. It is meant to be used along with diabetes and exercise. Byetta is not approved for use in patients with type 1 diabetes or to treat diabetic ketoacidosis. It is also not approved for use along with insulin.
Byetta is injected subcutaneously two times a day.
Why are there Byetta lawsuits?
Since Byetta was first introduced on the market, it has been linked to cases of acute pancreatitis, hyperglycemia, hypoglycemia and severe allergies. It has also been linked to altered kidney function and renal kidney failure.
According to the US Food and Drug Administration (FDA), since 2005, the agency has received 40 reports of patients developing acute pancreatitis after exposure to Byetta. Of those, six people died and 21 required hospitalization. Furthermore, FDA received reports of 78 patients who developed kidney problems, including 62 cases of renal kidney failure.
What is pancreatitis?
Pancreatitis is an inflammation of the pancreas. Acute, hemorrhagic and necrotizing pancreatitis are severe forms of pancreatitis. Hemorrhagic pancreatitis results in severe bleeding caused by erosion of the blood vessels; necrotizing pancreatitis involves damage of the tissues, which results in toxins and enzymes being released into the patient's bloodstream which can then cause organ failure and death.
What are the symptoms of pancreatitis?
Symptoms of pancreatitis include severe abdominal pain that may radiate to the back. This pain may or may not be accompanied by vomiting.
What are the symptoms of kidney problems?
Symptoms of kidney problems include nausea, vomiting and diarrhea; changes in urine color; changes in frequency of urination; fatigue; swelling in the hands or feet; changes in appetite or digestion; and dull aches in mid to lower back.
What should I do if I'm taking Byetta?
If you are taking Byetta, be on the lookout for signs or symptoms of kidney problems or pancreatitis. Talk to your doctor if you are at all concerned about taking the medication. Do not discontinue medication without consulting your healthcare professional.
What has the FDA said about Byetta? Have there been Byetta FDA Warnings?
Byetta was approved by the FDA in April, 2005. On October 16, 2007, the FDA required Amylin and Eli Lilly to include more prominent warning labels alerting patients to the risk of Byetta side effects, including reports of acute pancreatitis. This was mandated after the FDA reviewed 30 cases of pancreatitis.
On August 18, 2008, the FDA issued a healthcare provider alert, warning physicians about six more cases of necrotizing or hemorrhagic pancreatitis among Byetta users. Of those six cases, two resulted in death.
On November 2, 2009, the FDA warned physicians and patients to pay attention to potential symptoms of kidney problems. The warning was based on reports of possible kidney function problems in patients who used Byetta. According to the FDA, from April 2005 through October 2008, the agency received 78 reports of kidney function problems in patients who used Byetta.
Who manufactures Byetta?
Byetta is manufactured by Amylin Pharmaceuticals, Inc. Eli Lilly and Company is a partner in Byetta's development and marketing.
What has occurred in Byetta litigation?
Lawsuits have been filed against Amylin Pharmaceuticals and Eli Lilly & Company, alleging the companies failed to adequately warn patients about the risks of pancreatitis associated with use of Byetta.
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Last updated on Jul-14-10