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Diabetes Drugs Januvia and Janumet 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. According to the FDA, the diabetes drug, Sitagliptin (marketed as Januvia and Janumet) may cause an increased risk of pancreatic cancer in patients using JanuviaIf 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 Januvia or Janumet, please report the adverse action to the prescribing medical doctor as soon as possible.  For more information on a potential legal claim regarding Januvia, please contact Januvia Pancreatic Cancer Lawyer Jason Coomer a Texas lawyer, or use our online submission form for a free consultation .

The Diabetes Drug Market is Over $40 Billion Each Year and Growing Rapidly: Januvia and Janumet had Annual Sales of $4.7 Billion in 2011

More than 300 million people worldwide suffer from diabetes, including about 30 million Americans.  In 2010, the global prevalence of diabetes was estimated to have reached 285 million and predicted to reach 438 million in 2030. The corresponding figures for North America were 37.4 million in 2010 and 53.2 million by 2030 and in Europe 55.2 million in 2010 and 66.2 million in 2030.  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.

Merckís Januvia (sitagliptin) is the first in a new class of diabetic drugs called dipeptidyl peptidase-4 (DPP-4) inhibitors.  It is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

In 2011, Januvia annual sales rose 39%, to $3.3 billion, from $2.4 billion the year before and $1.9 in 2009. Januvia along with its sister drug Janumet (a combination of Januvia and metformin) has combined for sales of $4.7 billion for 2011.  Sales of Januvia and Merckís Januvia (sitagliptin) is approved in all major markets and have outdone initial estimates for the drugs. 

FDA Revision of safety information on Sitagliptin (marketed as Januvia and Janumet)

Between October 16, 2006 and February 9, 2009, the FDA received 88 post-marketing cases of acute pancreatitis, of which 66 required hospitalization. The FDA review also found that in over half of these cases, the patientís pancreatitis resolved once Januvia was discontinued. While diabetics are more vulnerable to developing pancreatitis than those without the disease, it does appear that taking Januvia can potentially increase that risk. And, if pancreatitis becomes chronic, the inflammation of the pancreas will alter its normal structure and functions.

As of September 2009, the FDA is revising the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products.

 The FDA is recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products. Information noting that sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis while using sitagliptin or sitagliptin/metformin. Sitagliptin or sitagliptin/metformin should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.

Pancreatic cancer is one of the most deadly of all types of cancer.  It is the fourth leading cause of cancer death for both men and women.  Each year approximately 45,000 Americans are 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 Januvia or Janumet, 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.


Pancreatic Cancer, Exocrine Pancreas Cancers (Pancreatic Adenocarcinoma) and Endocrine Pancreatic Cancers

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, Hemorrhagic Pancreatitis, Necrotizing Pancreatitis

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.

Several medications, products, and drugs have been linked pancreatitis.  Some of these medications were intentionally marketed by drug manufacturers while hiding the real dangers of their product in order to sell more of their product and seemingly valuing profits over the health of their customers.  For these manufacturers, they may have short term profits, but over the long term they should be held accountable for the insurmountable harm  that they have caused people who unwittingly took their product.


Potential Lawsuits for victims of Pancreatic cancer as a result of taking Janumet or Januvia

Texas Pancreatic Cancer Attorney, Jason Coomer, commonly works with other lawyers in Texas amd throughout the nation  who are investigating potential Januvia lawsuits on behalf of diabetics who took Januvia or Janumet and have suffered from acute pancreatitis (including hemorrhagic or necrotizing pancreatitis.)  By sharing information and working together, his law firm and other firms throughout the nation are able to provide better representation for there clients.  As Lawyers we seek compensation from negligent drug companies, medical providers, and other companies that have severely injured their customers through selling and using dangerous toxic products, medications, and drugs that they did know or should have know were dangerous, but instead decided to conceal significant research in order to sell more product to make a profit. 

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 Januvia or Janumet, please report the adverse action to the prescribing medical doctor as soon as possible.   For more information on a potential legal claim regarding Januvia, please contact Januvia Pancreatic Cancer Lawyer Jason Coomer (a Texas lawyer,) or use our online submission form for a free consultation .

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