Pancreatic Cancer Linked to Januvia & Byetta

Januvia and Byetta are the flagship drugs in a new kind of diabetes treatment known as “incretin therapy,” which has been heralded as a safe and effective way for type 2 diabetics to maintain blood sugar levels.  But a storm of controversy is brewing around these new treatments due to studies that show a link between medicines like Januvia and Byetta and pancreatic cancer and accusations that drug manufacturers are being less than forthcoming with their data about potential side effects and risks of the medications.

Drug companies dispute the connection between Januvia and pancreatic cancer, citing the increased risk that all diabetes patients face of suffering pancreatic illness, but researchers and watchdog groups say there is cause for concern, pointing to animal trials, FDA adverse drug event reports, and studies of pancreatic tissue from organ donors to support calls for more study.  The FDA and the European Medicines Agency have issued statements that they are studying information on the association between pancreatic cancer and Byetta or Januvia to look for evidence that the drugs are causing the cancer.

Pancreatic cancer

Pancreatic cancer is one of the deadliest cancers, responsible for the fourth largest number of cancer deaths in the U.S.,  and killing most patients within a year of diagnosis.  Part of the reason that pancreatic cancer is so deadly is that symptoms rarely show up until the late stages of the cancer, when it is inoperable and incurable.

When symptoms of pancreatic cancer appear, they may include:

• significant weight loss along with abdominal pain
• abdominal pain that is worse at night or when lying down
• constipation
• diarrhea
• gas pains
• bloating
• nausea
• vomiting
• loss of appetite
• jaundice
• bloody stools
• weakness
• itching
• dark urine and light stools
• blood clots in the legs
• sudden mood change, such as depression

Diagnosis & treatment of pancreatic cancer

Because of the association between pancreatic cancer and Januvia and Byetta, patients taking these drugs may want to opt for early screening.  Scientists are working on promising new methods to catch the cancer early using blood tests that look for proteins or metabolites associated with the disease.  Unfortunately, most of these methods are not yet widely available and most patients will not be diagnosed until the cancer is symptomatic.

Once symptoms occur, doctors can use imaging, blood tests, or surgical biopsy to determine the cause.  A CT scan, MRI, ultrasound, or PET scan can be used to observe the pancreas and look for signs of cancer.  If potentially cancerous tissue is spotted, doctors will then take a small sample of the tissue using a needle or an endoscope.

If doctors confirm pancreatic cancer, they will recommend the best way to proceed based on how advanced the disease is.  If the cancerous tissue can be removed surgically, doctors will perform a surgery called the Whipple procedure that removes parts of the pancreas, stomach, and the small intestine, along with the bile duct, gall bladder, and some lymph nodes.  This surgery itself is very difficult and can lead to complications and a long recovery period.

If surgery is not an option, doctors will order chemotherapy and/or radiation therapy to try to reduce and slow the growth and spread of the cancer.  Doctors may also resort to pain management and symptom control in order to provide as much comfort as possible during the patient’s last months.

Januvia and pancreatic cancer

The controversy surrounding potential Januvia side effects such as pancreatic cancer began in 2008 when a doctor studying the drug discovered precancerous changes in the pancreases of rats given the medication.  While Dr. Peter C. Butler of UCLA followed up on his initial findings by studying pancreatic tissue taken from human organ donors, he found a 40% higher risk of a pancreatic mass in patients taking Januvia and similar drugs when compared to patients taking other diabetes drugs or taking no diabetes drugs.

By late 2012, the FDA had received adverse event reports about Januvia linking the drug to 834 cases of pancreatitis and 184 cases of acute pancreatitis – a condition that is considered a risk factor for pancreatic cancer.  The FDA had also received 139 reports of pancreatic cancer in Januvia patients, including 33 cases where the patient had already died at the time of the report.  An analysis of FDA adverse event reporting data showed a 2.7-fold increase in the incidence of pancreatic cancer reports in Januvia patients over patients taking an older and better-studied diabetes medication.

Byetta and pancreatic cancer

Studies of Byetta and pancreatic cancer show that the drug could be even more dangerous than Januvia.  The FDA has received 3597 reports of pancreatitis and 1304 reports of acute pancreatitis from Byetta.  Pancreatic cancer was reported in 319 Byetta patients, with 88 deaths reported so far.  Analysis of reports of Byetta and pancreatic cancer incidence show the drug elevates the risk to 2.9 times that of traditional diabetes therapies.

Januvia and Byetta pancreatic cancer lawsuits

The companies that design, manufacture and market Byetta and Januvia, including Merck & Co., Amylin, Eli Lilly, and Bristol-Myers Squibb, are now facing a wave of litigation over the allegedly dangerous and defective products.  Bristol-Myers reports more than 100 lawsuits representing 575 plaintiffs seeking compensation for damages caused by Byetta, including pancreatitis and pancreatic cancer, in state and federal courts across the country.  Merck says they face 43 lawsuits alleging pancreatic cancer caused by Januvia.  Byetta and Januvia lawsuits are likely to be consolidated in a federal court in California in order to streamline the cases for pretrial proceedings and encourage quick settlements and justice for pancreatic cancer victims.