Byetta and other diabetes drugs have been linked to an increased risk of thyroid cancer and pancreatic cancer. Persons taking diabetes drugs and medical providers that are prescribing diabetes drugs should be aware of thyroid cancer risks and pancreatic cancer risks as well as be aware of cancer detection protocols. Early detection of cancer is essential to preventing the spread of cancer and important to surviving cancer. Persons that have been taking diabetic drugs and have been diagnosed with thyroid cancer or pancreatic cancer should report the cancer to both their medical provider and the FDA. Families of loved ones who took diabetes drugs and lost their lives to thyroid cancer or pancreatic cancer should also report the cancer to the FDA.
In addition to reporting thyroid cancer and pancreatic cancer caused by diabetes drugs, it is important that cancer survivors and families that have lost loved ones to diabetes drug cancers file lawsuits to prevent large drug companies from continuing to profit from selling dangerous drugs. For more information on diabetes drug cancer lawsuits, please contact Diabetes Drug Cancer Lawyer, Byetta Pancreatic Cancer Lawyer, and Byetta Thyroid Cancer Lawyer, Jason S. Coomer, for a free case review of a Diabetes Drug Cancer Lawsuit or use our online submission form.
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.
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.
In November 2009, the FDA revised the prescribing information for Byetta to include information on reported cases of acute pancreatitis in patients using this drug. Below is information from the FDA regarding Byetta safety warnings.
Byetta Safety Update for Healthcare Professionals
As part of our ongoing efforts to keep you informed, we want to make you aware of recent safety information for Byetta, an anti-diabetic drug. On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.
The REMS is the result of new safety information associated with the use of Byetta, including postmarketing reports of acute pancreatitis and altered kidney function. 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).
Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.
To ensure that healthcare professionals and patients fully understand the benefits and potential risks associated with the use of Byetta, the REMS contains several elements including:
A Medication Guide given to patients each time they receive a prescription for Byetta from a pharmacy. The Medication Guide explains the benefits and risks associated with using Byetta A Communication Plan requiring the manufacturer of Byetta to distribute a Dear Healthcare Professional letter discussing the potential for altered kidney function to occur in patients using Byetta Evaluating healthcare professional and patient understanding of the potential for acute pancreatitis and altered kidney function in patients using Byetta
Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.
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 there clients.
Home News & Events Newsroom Press Announcements
- FDA NEWS RELEASE
For Immediate Release: Nov. 2, 2009
Media Inquiries: Sandy Walsh, 301-796-4669, email@example.com Consumer Inquiries: 888-INFO-FDA FDA: Byetta Label Revised to Include Safety Information on Possible Kidney Problems
The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.
From April 2005 through October 2008, the FDA received 78 reports of problems with kidney function 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.
Nearly 7 million prescriptions for Byetta were dispensed between April 2005 and September 2008. The 78 cases represent a small percentage of the total number of patients using the drug to control blood sugar (glucose) levels.
The most common side effects associated with Byetta include nausea, vomiting, and diarrhea. These side effects may have contributed to the development of altered kidney function. Kidney malfunction can result in a build-up of waste products in the blood, leading to serious illness or life-threatening conditions.
?Health care professionals and patients taking Byetta should pay close attention to any signs or symptoms of kidney problems,? said Amy Egan, M.D. M.P.H., of the Division of Metabolism and Endocrinology Products at the FDA?s Center for Drug Evaluation and Research. ?Patients also should be aware that problems with kidney function could lead to changes in urine color, frequency of urination or the amount of urine, unexplained swelling of the hands or feet, fatigue, changes in appetite or digestion, or dull ache in mid to lower back.?
Patients who experience any of these symptoms should immediately discuss them with their health care professional.
Exenatide (marketed as Byetta) Information
[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.
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. 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 pancreas is a large organ located behind the stomach and in front of the spine above the level of the belly button. The pancreas performs two main functions: 1) it makes insulin, a hormone that regulates blood sugar levels, and 2) it makes enzymes. The pancreas makes and releases enzymes into the intestines that help the body absorb foods, especially fats. The pancreas is made of Exocrine cells and Endocrine cells. Exocrine cells are cells that produce a pancreatic juice that includes enzymes which aid in the digestion of food in the small intestine, breaking up proteins, carbohydrates, and fats.
The most common kind of pancreatic cancer is pancreatic adenocarcinoma and includes about 90% of the cases of pancreatic cancer. Pancreatic adenocarcinoma is a cancerous overgrowth of exocrine pancreatic cells and is unfortunately commonly undetected until it is too late for the patient. Pancreatic adenocarcinoma because of late detection can often result a fatal diagnosis with very limited survival time. Other forms of exocrine pancreas cancer include: intraductal papillary mucinous neoplasm (IPMN), adenosquamous carcinomas, acinar cell carcinomas, mucinous cystadenocarcinomas, signet ring cell carcinomas, hepatoid carcinomas, colloid carcinomas, undifferentiated carcinomas, pancreatoblastomas, and undifferentiated carcinomas with osteoclast-like giant cells.
Endocrine cells are clustered in small groups (called the Islets of Langerhans) scattered throughout the pancreas. These endocrine cells produce important hormones such as insulin, glucagon, and somatostatin. The hormones called insulin and glucagon help your body control blood sugar levels. Tumors can also occur in these cells, but they are called islet cell tumors and are rare.
The exact cause of pancreatic cancer is unknown. However, it is more common in people with diabetes and people with long-term inflammation of the pancreas (chronic pancreatitis). It is also thought that the use of Byetta can cause pancreatitis resulting in pancreatic cancer.
Symptoms of pancreatic cancer can include: dark urine and clay-colored stools, fatigue and weakness, jaundice (a yellow color in the skin, mucus membranes, or eyes), loss of appetite and weight loss, nausea and vomiting, pain or discomfort in the upper part of the belly or abdomen, back pain, blood clots, diarrhea, and indigestion.
Pancreatic cancer is often not detected early on and is often advanced when it is first found. As such, ninety-five percent of the people diagnosed with this cancer will not be alive 5 years later. Some patients have pancreatic cancer that can be surgically removed are cured. However, in more than 80% of patients the tumor has already spread and cannot be completely removed at the time of diagnosis. In the few cases where pancreatic tumors can be removed by surgery. The standard surgical procedure to remove pancreatic tumors is called a Whipple procedure (pancreatoduodenectomy or pancreaticoduodenectomy). This surgery should be done by an experienced surgeon and at a medical center that performs the procedure often. Some studies suggest that the Whipple procedure is best performed at hospitals that do more than five of these surgeries per year.
When the tumor has not spread out of the pancreas, but cannot be removed, radiation therapy and chemotherapy together may be recommended. When the tumor has spread (metastasized) to other organs such as the liver, chemotherapy alone is usually used. The standard chemotherapy drug is gemcitabine, but other drugs may be used. Gemcitabine can help about 25% of patients.
Patients whose tumor cannot be totally removed, but who have a blockage of the tubes that transport bile (biliary obstruction) must have that blockage relieved. There are two approaches including surgery and placement of a tiny metal tube (biliary stent) during ERCP.
Managing pain and other symptoms is an important part of treating advanced pancreatic cancer. Palliative care tams and hospice can help with pain and symptom management, and provide psychological support for patients and their families during the illness.
Acute pancreatitis is a sudden inflammation of the pancreas that occurs over a short period of time. The pancreas is a digestive organ behind the stomach that secretes essential enzymes needed for the digestion of certain foods, including fats, carbohydrates and proteins. During an episode of acute hemorrhagic pancreatitis, several symptoms relating to digestion and abdomen may occur. In severe cases, the person may experience confusion, difficulty breathing, or respiratory failure. The person may also fall into a coma.
The severity of acute pancreatitis may range from mild abdominal discomfort to a severe, life-threatening illness. However, the majority of people with acute pancreatitis (more than 80%) recover completely after receiving the appropriate treatment. In very severe cases, acute pancreatitis can result in bleeding into the gland, serious tissue damage, infection, and cyst formation. Severe pancreatitis can also create conditions which can harm other vital organs such as the heart, lungs, and kidneys.
The warning signs of pancreatitis include: 1) Upper abdominal pain that radiates into the back. Patients may describe this as a "boring sensation" that may be aggravated by eating, especially foods high in fat. 2) Swollen and tender abdomen 3) Nausea and vomiting 4) Fever and 5) Increased heart rate.
Acute hemorrhagic pancreatitis is the sudden inflammation of the pancreas. This leads to death of pancreatic tissue and the formation of lesions, causing extensive bleeding.
Necrotizing pancreatitis is a serious health condition where a person's pancreas is inflamed and bleeding. In Necrotizing Pancreatitis patients, there is inflammation and tissue death, with the pancreas destroying itself. Whereas in Hemorrhagic Pancreatitis patients, the pancreas is bleeding. Both are serious conditions and should be treated immediately.
Texas Pancreatic Cancer Attorney, Jason Coomer, commonly works with other lawyers throughout the nation including Chicago Byetta Pancreatitis Lawyers, Boston Byetta Thyroid Cancer Lawyers, New York Byetta Cancer Attorneys, California Diabetes Drug Pancreatitis Attorneys, and Houston Byetta Cancer Lawyers,. By sharing information and working together, his law firm and other firms throughout the nation 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. For more Byetta Pancreatic Cancer Lawsuit, Byetta Cancer Death Lawsuit, or Byetta Pancreas Cancer Lawsuit information, please feel free to contact Byetta Pancreatic Cancer Lawyer, Byetta Cancer Lawyer, and Byetta Pancreas Cancer Death Lawyer Jason Coomer a Texas lawyer, or use our online submission form.