Pancreatic Cancer and the Onglyza® Lawsuit

About Onglyza®

The goal of Onglyza® therapy is to help type 2 diabetics control their blood sugar levels and avoid long-term health complications. One of several incretin-based medications available today, Onglyza® has been widely prescribed since 2009. Before reports of complications, the medication had been a popular choice among patients because it does not cause the weight gain that is associated with other diabetes drugs.

Onglyza® and other incretin mimetic drugs have been linked to pancreatic conditions in clinical studies, and a 2013 article suggested a potential connection to pancreatic cancer.

Onglyza® belongs to a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. These types of drugs work by suppressing the ability of the DPP-4 enzyme to metabolize glucagon-like peptide-1 (GLP-1). This hormone is produced by alpha cells in the pancreas and signals the liver to release glucose into the bloodstream. Saxagliptin works to prevent DPP-4 from breaking down GLP-1, so that the hormone remains active in the body for a longer period of time.

AstraZeneca partnered with Bristol-Myers Squibb to introduce Kombiglyze XR® in 2011. This extended release formulation combines saxagliptin with metformin, another diabetes medication. Similar to Onglyza®, it is prescribed to be taken orally once a day.

Pancreatic Cancer and Other Complications

Onglyza® and other incretin mimetic drugs have been linked to pancreatic conditions in clinical studies, and a 2013 article suggested a potential connection to pancreatic cancer. The FDA responded to the published research by issuing a 2013 safety communication to warn patients and doctors about the risks.

A publication of the American Diabetes Association reported findings of pre-cancerous tumors in organ donors who died after taking incretin therapy drugs. After conducting autopsies, researchers found an increased incidence of pancreatic masses in patients treated with incretin therapy. These conclusions suggest that patient taking these medications may need to be closely monitored for any potential dangers. The researchers stated,  “these findings lend additional weight to concerns regarding the effects of long-term GLP-1-related therapy…. and now also a possible increased risk of neuroendocrine tumors.”

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Another report, known as SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) found an increased incidence of pancreatitis in a study of over 16,000 patients. The researchers also connected heart failure and other adverse health complications to the use of this drug, and noted “a potential increase in all-cause mortality with saxagliptin.”

SAVOR was a randomized, double-blind, placebo-controlled study, which prompted the FDA to order additional warning labels for Onglyza®, Kombiglyze XR®, and several other drugs. In April 2016, the FDA issued a Drug Safety Communication about the issue of heart failure and announced updated warning labels for drugs containing saxagliptin, as well as other DPP-4 inhibitors. The agency had already issued a 2015 warning about reports of severe joint pain among Onglyza® patients.

Inflammation of the Pancreas

The pancreas plays an important role in human digestion, releasing enzymes into the small intestine to help metabolize food. The pancreas also releases insulin into the bloodstream and is responsible for maintaining the body’s blood glucose levels. This large gland is located deep inside the abdomen between the stomach and the spine, adjacent to the liver and gallbladder.   

Pancreatitis is a condition that occurs when the pancreas becomes inflamed. There are several potential causes, including heavy alcohol consumption and the use of certain medications. The condition is considered acute when it arises suddenly and lasts for a short period of time, causing discomfort that can range from mild to severe. Severe acute pancreatitis can cause tissue damage, infection, and formation of cysts, potentially causing damage to the heart, lungs, and kidneys as well.

The symptoms of acute pancreatitis include:

• Upper abdominal pain, which radiates into the back
• Swollen, tender abdomen
• Nausea and vomiting
• Fever
• Increased heart rate

Doctors can perform several tests to diagnose pancreatitis. Treatment typically consists of intravenous (IV) fluids and pain medication. In severe cases, surgery may be needed to remove dead or damaged pancreatic tissue.

Pancreatic cancer is the third leading cause of cancer-related death in the U.S.

Repeated episodes of acute pancreatitis can lead to the long-term form of the condition. Chronic pancreatitis is difficult to treat, and must be managed with diet and pain medication. Chronic pancreatitis is also considered a major risk factor for pancreatic cancer.

Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related death in the U.S. The American Cancer Society estimates about 53,070 new cases in 2016, leading to 41,780 deaths. Pancreatic cancer is often not discovered until it reaches an advanced stage. The symptoms can be vague and similar to other disorders, but a distinctive hallmark is jaundice, a yellowing of the skin and eyes. Other potential symptoms include:

• Pain in the abdomen or back
• Weight loss
• Fatigue

Pancreatic cancer can be diagnosed with blood analysis and imaging studies, including ultrasound, X-rays, and CT scans, as well as more advanced diagnostic tests. Your doctor will provide a diagnosis of the stage of the malignancy by determining tumor size and whether cancer has spread to nearby lymph nodes or other organs. Treatment may include a combination of chemotherapy, radiation, and surgery.

Multidistrict Litigation

As commonly occurs in product liability cases, claims in the Onglyza® lawsuit are likely to be consolidated into multidistrict litigation (MDL). When many plaintiffs have similar claims against a common defendant, MDL is an efficient way to handle them. This type of litigation is preferable to class action lawsuits, because MDL plaintiffs are able to retain their own attorneys and receive individualized settlements or jury awards.

Contact a Qualified Pharmaceutical Liability Attorney

If you have taken Onglyza® or Kombiglyze XR® and suffered a serious complication, it is imperative that you speak with an experienced pharmaceutical attorney to discuss your legal rights. Each state has specific time requirements to file a claim before the manufacturer of the drug is released from liability. Please contact our legal team to arrange a complimentary case evaluation.