Byetta & Januvia Investigation

Stueve Siegel Hanson is investigating the prescription drugs Byetta and Januvia related to an increased risk of pancreatic cancer.  Byetta, manufactured by Amlyin, and Januvia, manufactured by Merck, belong to a family of drugs known as Incretin mimetic drugs and help to stimulate the production of insulin in diabetic patients by mimicking the incretin hormones responsible for insulin production, and have been shown to lower blood sugar levels in patients with type 2 diabetes. They are intended to be used in combination with lifestyle changes, including proper nutrition and exercise.

Januvia (stiagliptin) is a member of the incretin mimetic drug family, but is also considered a dipeptidyl peptidase-4 inhibitor.  Byetta (exenatide) is a twice daily injectable medication introduced in 2005.  A longer-acting version of this drug, Bydureon, was released in 2012.

Hundreds of complaints have been made to the FDA detailing complications and adverse effects in users of Byetta and Januvia.  Studies have shown that side effects of Byetta and Januvia can include pancreatitis and pancreatic cancer, one of the most deadly forms of cancer.

Symptoms of pancreatic cancer may include:

  • Pain in the upper abdomen or upper back
  • Loss of appetite
  • Nausea or vomiting
  • Weakness
  • Fatigue
  • Chills
  • Cramping
  • Abdominal distention
  • Unexplained weight loss
  • Itchiness
  • Jaundice (yellowing of the eyes and skin)

Patients who are taking Januvia or Byetta and who experience these symptoms should contact their doctors.

Beginning in 2007, the FDA began issuing multiple healthcare provider alerts noting the increased risk of acute pancreatitis in patients taking Byetta including both hemorrhagic and necrotizing pancreatitis. Pancreatitis involves an inflammation of the pancreas, which requires immediate medical attention and may result in the need for hospitalization. The condition is associated with severe upper abdominal pain, nausea and vomiting. Chronic pancreatitis has been linked to a potential increased risk of pancreatic cancer and other health problems.

One such alert, “FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes” dated March 13, 2013, states the they are evaluating findings of an increased risk of pancreatitis and pancreatic duct metaplasia in patients being treated with Byetta and Januvia among other drugs.

Additionally, a recent medical journal article has been published detailing a study concerning Byetta and Januvia and their possible link to an increased risk of pancreatic cancer and pancreatitis. “Glucagonlike Peptide 1–Based Therapies and Risk of Hospitalization for Acute Pancreatitis in Type 2 Diabetes Mellitus” was published online by The Journal of the American Medical Association (JAMA) on February 25, 2013. The case-control study looked at 2,538 adults with type 2 diabetes, half of whom were hospitalized with acute pancreatitis. They found a number of factors that increased the risks of pancreatitis, such as smoking, drinking and obesity, but once they adjusted for those factors, they determined that patients who had used Januvia or Byetta in the last 30 days were twice as likely to be hospitalized by acute pancreatitis.

Despite these concerns, Merck has insisted that there has not been sufficient evidence to suggest a causal relationship between Januvia and pancreatic injuries. Bristol-Myers has acknowledged that Byetta has been associated with pancreatic injuries, but insists that the drug’s benefits outweigh the risk.

Given that 25 million Americans have type 2 diabetes, the control medications for the disease are a huge market, with more than $40 billion in annual sales in the United States alone. Januvia is one of Merck’s best sellers, providing well over $2 billion in annual revenue. Annual sales of Byetta are nearly $1 billion a year. The potential for huge profits, and the presence of serious competition —  there are over two dozen Type 2 diabetes medications on the market today – makes the incentive to get the drugs on the market without properly investigating them a big concern.

Currently, several Byetta pancreatic cancer and Januvia pancreatic cancer lawsuits are pending in federal and state courts across the United States. Stueve Siegel Hanson is investigating claims of patients experiencing serious side effects caused by Byetta or Januvia. If you wish to receive additional information about your legal options, please call 1.888.756.6494.

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