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The Injectable Diabetes Drug Byetta May Cause Pancreatitis and Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer death for both men and women and is one of the most deadly of all types of cancer. The injectable diabetes drug, Byetta (Exenatide), may cause an increased risk of pancreatic cancer in patients using ByettaIf you have lost a loved one from Pancreatic Cancer or have suffered acute pancreatitis, hemorrhagic pancreatitis, accute necrotizing pancreatitis, or pancreas cancer; and have been using Byetta (Exenatide), please report the adverse action to the prescribing medical doctor as soon as possible.  You may also be entitled to compensation for your injuries and we can help.  For more information on a potential Byetta Pancreatic cancer lawsuit, please feel free to contact Byetta Pancreatic Cancer Lawyer, Jason Coomer a Texas lawyer, or use our online submission form.



Pancreatic Carinoma, Pancreatic Cancer, and Cancer Pancreas

This year approximately 45,000 Americans will be diagnosed with pancreatic cancer and about 38,000 will die from it.

Unfortunately, pancreatic cancer is difficult to diagnose, and the diagnosis is often made late in the course of the disease.  Early detection of pancreatic cancer is essential and will greatly improve a person's chances of surviving the disease. As such, people that have taken Byetta, especially those with symptoms of weight loss, dark urine and clay-colored stools, back pain, and jaundice, should seek advice from a qualified medical professional as to if they may have pancreatic cancer and what symptoms they should be aware of to detect any early onset of pancreatic cancer.

The Diabetes Drug Market is Over $40 Billion Each Year and Growing Rapidly Byetta had Annual Sale of Over $500 Million in 2010

More than 300 million people worldwide suffer from diabetes, including nearly 26 million Americans.  The global market for products in the management of diabetes currently stands at $41 billion and is on pace to grow to over $114 billion by 2018.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes. Byetta exhibits many of the same effects as the human incretin hormone GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.  Byetta was approved in the U.S. in April 2005 and in Europe in November 2006 and has been used by more than 1.8 million patients since its introduction. Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008.  In 2010 Byetta sales were over $500 million. 

Unfortunately safety issues with Byetta began to emerge not long after its approval by the FDA.  It appears that Byetta was not as safe as previously thought and it is believed that the makers of the drug should have been aware of such a strong correlation between Byetta and Pancreatic cancers before they put it on the market.

FDA Responds to Reports that Byetta (Exenatide) and Byetta (Exenatide) May Cause an Increased Risk of Hemorrhagic Pancreatitis and Necrotizing Pancreatitis

10/2007: the FDA has reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, a drug used to treat adults with type 2 diabetes.  An association between Byetta and acute pancreatitis is suspected in some of these cases. 

The FDA suggests healthcare professionals should instruct patients taking Byetta to seek prompt medical care if they experience unexplained persistent severe abdominal pain which may or may not be accompanied by vomiting.  If pancreatitis is suspected, Byetta should be discontinued.  If pancreatitis is confirmed, Byetta should not be restarted unless an alternative etiology is identified.

Because of these findings the FDA has asked and the maker of Byetta, Amylin Pharmaceuticals, Inc. has agreed to include information about acute pancreatitis in the PRECAUTIONS section of the product label. 

Update [8/18/2008]: The FDA received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Byetta is a medicine given by subcutaneous injection to help treat adults with type 2 diabetes. Of the 6 cases of hemorrhagic or necrotizing pancreatitis, all patients required hospitalization, two patients died and four patients were recovering at time of reporting.  Byetta was discontinued in all 6 cases.   

Byetta and other potentially suspect drugs should be promptly discontinued if pancreatitis is suspected.  There are no known patient characteristics which determine when pancreatitis associated with Byetta will be complicated by the hemorrhagic or necrotizing forms of this condition. If pancreatitis is confirmed, initiate appropriate treatment and carefully monitor the patient until recovery.  Byetta should not be restarted.  Consider antidiabetic therapies other than Byetta in patients with a history of pancreatitis.

FDA is working with the maker of Byetta, Amylin Pharmaceuticals, Inc., to add stronger and more prominent warnings in the product label about the risk of acute hemorrhagic or necrotizing pancreatitis.

Update [11/02/2009] FDA has approved revisions to the drug label for Byetta (exenatide) to include information on post-marketing reports of altered kidney function, including acute renal failure and insufficiency. 

Byetta, an incretin-mimetic, is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

From April 2005 through October 2008, FDA received 78 cases of altered kidney function (62 cases of acute renal failure and 16 cases of renal insufficiency), in patients using Byetta. Some cases occurred in patients with pre-existing kidney disease or in patients with one or more risk factors for developing kidney problems. From April 2005 through September 2008, more than 6.6 million prescriptions1 for Byetta were dispensed. Therefore, the 78 reported cases of altered renal function represent a small percentage of the total number of patients who have used the drug.

Some of the 78 patients reported nausea, vomiting, and diarrhea--the most common side effects associated with Byetta in clinical trials. These side effects may have contributed to the development of altered kidney function in the reported cases.

The revisions to the drug label allow healthcare professionals to better weigh the known benefits of Byetta with the potential risks that exist for certain patients.  Changes include:

  • Information regarding post-market reports of acute renal failure and insufficiency, highlighting that Byetta should not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease.
  • Recommendations to healthcare professionals that caution should be applied when initiating or increasing doses of Byetta from 5 mcg to 10 mcg in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min).
  • Recommendations that healthcare professionals monitor patients carefully for the development of kidney dysfunction, and evaluate the continued need for Byetta if kidney dysfunction is suspected while using the product.
  • Information about kidney dysfunction in the patient Medication Guide to help patients understand the benefits and potential risks associated with Byetta.

Acute pancreatitis was previously listed in the prescribing information for Byetta, but more severe forms of pancreatitis, including hemorrhagic and necrotizing pancreatitis, have been reported to FDA since the initial label update. FDA issued safety communications on these adverse event reports in 2007 (acute pancreatitis), 2008 (hemorrhagic and necrotizing pancreatitis) and 2009 (altered kidney function).

Byetta Pancreatic Cancer Lawsuit Information, Byetta Pancreas Cancer Lawsuit Information, and Byetta Cancer Death Lawsuit Information

Byetta Pancreas Cancer Lawsuits and Byetta Pancreatic Cancer Lawsuits are in the process of being reviewed and filed as recent scientific evidence indicates that the injectable diabetes drug, Byetta (Exenatide), may cause an increased risk of pancreatitis, this side effect can and often does lead to the development of pancreatic cancer.  Pancreatic Cancer is an extremely deadly form of cancer.  Most people diagnosed with Pancreatic Cancer or Cancer of the Pancreas do not survive beyond the five years and many are given much less time as Pancreatic Cancer is hard to detect.  Early detection is the key to surviving pancreatic cancer.

Diabetics are more vulnerable to developing pancreatitis than those without the disease, recent studies indicate that taking Byetta can potentially increase the risk of pancreatitis. And, if pancreatitis becomes chronic, the inflammation of the pancreas will alter its normal structure and functions.  This can lead to pancreatic cancer.

Prior 2009, the FDA received more than 30 reports of acute pancreatitis in Byetta users. Armed with this information, the FDA directed Amylin to conduct six post-marketing studies regarding acute pancreatitis associated with the use of Byetta, as well as to look at the risk of Byetta cancer, including thyroid cancer and pancreatic cancer. Additionally, the FDA has expressed concern that all extended-release diabetes drugs belonging to Byetta’s family of GLP-1 receptor agonists may be linked to thyroid tumors based on tests conducted on rats and monkeys.


 Byetta Pancreas Cancer Lawyers and Byetta Pancreatitis Lawyers

Texas Diabetes Drug Attorney, Jason Coomer, commonly works with other lawyers throughout the nation including National Pancreatic Cancer Lawyers, International Byetta Pancreatic Cancer Lawyers, Chicago Byetta Pancreatic Cancer Lawyers, Boston Byetta Pancreas Cancer Lawyers, New York Byetta Pancreatitis Attorneys, California Diabetes Drug Pancreatic Cancer Attorneys, Houston Byetta Cancer Lawyers, Florida Diabetes Drug Pharmaceutical Lawyers, Dallas Byetta Cancer Death Lawyers, and other Texas Dangerous Drug Claim Lawyers.  By sharing information and working together, his law firm and other firms throughout the nation and the world are able to provide better representation for their clients.  

If you have lost a loved one from Pancreatic Cancer or have suffered acute pancreatitis, hemorrhagic pancreatitis, accute necrotizing pancreatitis, or pancreas cancer; and have been using Byetta (Exenatide), please report the adverse action to the prescribing medical doctor as soon as possible.  You may also be entitled to compensation for your injuries and we can help.  For more information on a potential Byetta Pancreatic cancer lawsuit, please feel free to contact Byetta Pancreatic Cancer Lawyer,  Jason Coomer a Texas lawyer, or use our online submission form.

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