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Januvia and Pancreatic Cancer

Attention Januvia Users: Januvia and other similar medications are believed to be associated with an increase in the risk for pancreatic cancer. If you or someone you love is diagnosed with pancreatic cancer and you have a history of taking Januvia, you may be eligible for financial compensation. To find out if you qualify to file a Januvia lawsuit contact our attorneys today.

Januvia and Pancreatic Cancer Risk

The U.S. Food and Drug Administration (FDA) issued a safety communication March 14 saying it was reviewing new information about a possible link between Januvia and a risk of pancreatitis (inflammation of the pancreas) and precancerous cellular changes in the pancreas.

The researchers examined the relationship of the drug to these illnesses using tissue specimens from Type 2 diabetes patients after they died. The causes of death of the patients were unknown. The studies were done by scientists at the Larry L. Hillblom Islet Research Center at the University of California, Los Angeles and at the University of Florida and were published online in the journal "Diabetes."

In their studies, the researchers examined the pancreases of 20 diabetic organ donors who had died. Eight of these donors had taken Januvia or similar drugs in its class to treat their diabetes. Twelve donors, who also had diabetes had not been on these drugs. The researchers also studied the pancreases of 14 non-diabetic persons who were similar in age to the others.

The pancreases of those donors who had been on Januvia or similar drugs were enlarged and had cellular changes that are a risk factor for pancreatic cancer. There was a proliferation of other types of cells, called pancreatic alpha cells, which in previous studies had been shown to be linked to pancreatic tumors. The scientists said that their findings, based on only a small number of organ donors, should lead to further studies of a link between long-term use of Januvia and similar drugs and the development of pancreatic tumors.

Pancreatitis

The FDA said it wants to evaluate the work of the researchers for itself, and has asked the scientists for the methods they used to arrive at their conclusions and also requested some tissue samples in order to conduct its own studies. The agency cautioned that it has not yet found that Januvia and other drugs in its class were related to any new conclusions about the safety risks of the new drugs, but just wanted to keep the public and health care professionals informed of the recent information found by the scientists' work.

Januvia was approved in October 2006. As early as 2009, the FDA was alerting health care professionals to the possibility that acute pancreatitis was occurring in a number of patients taking Januvia. The FDA notice cautioned that doctors needed to be aware of the possibility of acute pancreatitis and be alert for signs of the disease in their patients taking Januvia.

Pancreatitis and Pancreatic Cancer

The American Cancer Society says there is an increased risk of pancreatic cancer in patients with chronic pancreatitis. This occurs most often in smokers. Januvia is known to be linked to acute pancreatitis.

Statistics on Pancreatic Cancer

The disease has been increasing slowly over the last ten years. According to 2013 statistics from the American Cancer Society:

  • Approximately 45,220 persons will be diagnosed with pancreatic cancer this year
  • Approximately 38,460 patients will die of pancreatic cancer in 2013
  • A person's lifetime risk of having pancreatic cancer is approximately one in 78 or 1.47 percent, although risk factors can change those numbers

Risk Factors For Pancreatic Cancer

  • Age — risk increased with age (almost nine people out of ten who get pancreatic cancer are over age 55; the average age when someone is diagnosed with pancreatic cancer is 71)
  • Being male — men are nearly 30 percent more likely to get pancreatic cancer than women
  • More African Americans than whites develop pancreatic cancer
  • Smoking — the risk of getting pancreatic cancer is at least two times as high among those who smoke; smokers who use smokeless tobacco are more likely to develop pancreatic cancer
  • Obesity and lack of physical activity
  • Diabetes
  • Chronic pancreatitis
  • Cirrhosis of the liver
  • Exposure of workers to pesticides, dyes and chemicals used to refine metals
  • Family history
  • Stomach infection with a bacterium that causes ulcers — helicobacter pylori
  • High fat diets (this has not been confirmed)
  • Alcohol

Symptoms of Pancreatic Cancer

Usually, no symptoms of pancreatic cancer are present in its early stages and it is diagnosed once it has spread beyond the pancreas. Because the organ is so deep within the body, it is not felt during a routine physical examination. Blood tests or genetic testing for the disease usually are not helpful in detecting the disease when it is in its early stages.

Diagnosing Pancreatic Cancer

With few initial symptoms, pancreatic cancer is not usually found in its early stages. Some earlier symptoms, however, include jaundice. This can be seen by the yellowing of a patient's eyes and skin, caused by a buildup of bilirubin in the body. Bilirubin is excreted by the liver.

Another reason for jaundice as a sign of some types of pancreatic cancer and where it occurs are tumors. The tumors, while they are still relatively small, compress the common bile duct. Jaundice results from this blockage. Pancreatic cancer also can lead to jaundice when cancer is in its more advanced stages and has spread to the liver. Other symptoms of jaundice include:

  • Brown urine
  • Lighter color stools
  • Yellow, itchy skin
  • Pain in the abdomen or back
  • Weight loss and poor appetite
  • Enlarged gall bladder
  • Blood clots and abnormalities in fatty tissues
  • Diabetes in rare cases
  • A variety of tumors that are diagnosed because of the changes they cause in chemicals in the blood stream

Tests to help diagnose pancreatic cancer include MRI (magnetic resonance imaging), CT (computed tomography) scans, SRS (somatostatin receptor scintigraphy), PET (positron emission tomography) scans, ultrasounds; ERCP (endoscopic retrograde cholangiopancreatography), x-ray angiography, blood tests to find the levels of a variety of body chemicals, biopsy of the pancreas.

Treating Pancreatic Cancer

Treatment options for pancreatic cancer are very limited. Surgery is one method of treatment, but is only a viable option for 15 percent of patients in whom the disease is caught before it has spread too widely to be operated on. Surgical patients often have chemotherapy or radiation therapy following their operations.

Drug therapy also is limited. Only two drugs have FDA approval to treat pancreatic cancer. One, gemcitabine, was approved in 1996. The other, erlotinib was approved in 2005. While these may benefit the patient, they are not expected to cure the disease.

Complications of Pancreatic Cancer

Jaundice is a primary complication of pancreatic cancer. Another is abdominal pain caused by tumors pressing on nerves. Bowel obstruction is another complication, as is weight loss. Pancreatic cancer is among the deadliest of all cancers. It is the fourth leading cause of death from cancer in the U.S. and has the highest death rate — 94 percent of all major cancers in the country. Compared to other cancers, the survival rate has not improved significantly in 40 years. Seventy-five percent of pancreatic cancer patients die within the first year of diagnosis.

Compensation May Be Available

If you are taking Januvia or a similar diabetes drug such as Byetta and have been diagnosed with pancreatic cancer, you should speak with one of our attorneys to find out if you qualify to file a Januvia lawsuit. Our attorneys are currently reviewing possible claims on behalf of diabetic patients who are diagnosed with cancer and who have a history of taking Januvia. To speak with an attorney about your circumstances, free of charge, please contact us today.

Januvia® (sitagliptin) is a Type 2 diabetes medication manufactured by Merck & Co., Inc. Januvia® is a registered trademark of Merck & Co., Inc.

Januvia® News

  • Januvia Sales Drop for the Quarter

    May 1st, 2013

    Sales of Merck's Januvia, a diabetes medication and the company's biggest seller, dropped for the first quarter of the year. The news, which was reported May 1, was surprising, Reuters said. Merck also lowered its full-year forecast today. Merck sales for the quarter dropped 9 percent to $10.7 billion, according to reports. That number is well below the $11.09 billion the market was expecting. The drug company... read more

  • Public Citizen Urges FDA to Ban Januvia Because of Cancer Risk

    April 15th, 2013

    Dr. Sidney Wolfe, Director of Public Citizen's Health Research Group, issued a statement last month, addressing the risk of precancerous changes in the pancreases of diabetic patients who use diabetes drugs Januvia (sitagliptin), Byetta (exenatide) and Victoza (liraglutide). According to the statement, Drs. Alexandra Butler and Peter Butler of the University of California, Los Angeles (UCLA) and colleagues published a study in the journal "Diabetes," showing... read more