An Increased Incidence of Pancreatitis in Patients Taking Onglyza®

Many patients have developed pancreatitis after being prescribed Onglyza® to help control type 2 diabetes, which has led to many lawsuits. The U.S. Food and Drug Administration (FDA) approved Onglyza® in 2009 to maintain consistent blood glucose levels in patients with type 2 diabetes. The medication is a DPP-4 inhibitor, which increases the pancreas’ ability to secrete insulin and suppresses the amount of sugar that is produced by the liver. This added stress on the pancreas is thought to increase a patient’s risk for pancreatitis, as well as pancreatic and thyroid cancers. Many of the claims that have been filed allege that the manufacturers of the drug failed to warn doctors and patients of these increased risks.

Illustration of the pancreas
Many Onglyza® patients have experienced pancreatitis, or inflammation of the pancreas.

Despite these potential complications and pending lawsuits, Onglyza® continues to be prescribed. In 2015, drug sales reached $786 million and are expected to reach billions in sales in US dollars before 2018. If you or a loved one was prescribed Onglyza® and suffered adverse health complications as a result, you may be entitled to significant compensation. Contact an experienced pharmaceutical attorney for a free case evaluation.

What is Pancreatitis?

Pancreatitis is inflammation of the pancreas. Serious cases of pancreatitis can result in hospitalization, and even lead to death if the condition is not treated in a timely manner. Chronic pancreatitis is also the leading risk factor for pancreatic cancer.

Chronic pancreatitis is also the leading risk factor for pancreatic cancer.

Onglyza® has resulted in numerous reports of patients developing acute pancreatitis. Although minor cases of acute pancreatitis can clear up without treatment, recurring cases of the condition can develop into chronic pancreatitis, resulting in a loss of function and an increased risk of developing pancreatic cancer. Despite the link to pancreatitis, it is unclear whether Onglyza® increases the risk of relapse in patients with existing pancreatitis or other pancreatic conditions.

According to the American Cancer Society, some patients are predisposed to pancreatitis and are more at risk of developing pancreatic cancer due to family history and genetics. Patients with type 2 diabetes are more prone to developing pancreatic cancer, regardless of which medication they are on, though the specific cause is unknown.

Studies and Articles Linking Onglyza® with Pancreatitis

A 2015 study led by the director of the University of Oxford Diabetes Trials Unit in the United Kingdom found that patients taking DPP-4 inhibitors or incretin mimetic medications, such as Onglyza®, had higher rates of acute pancreatitis and were at an increased risk of developing precancerous growths. The researchers involved in the study also noted that Onglyza® increased a patient’s risk for pancreatic surgery to treat pancreatitis, or to remove precancerous growths.

A 2013 study published in Diabetes found that deceased patients who had taken DPP-4 inhibitors, such as Onglyza®, had 40 percent larger pancreases when compared to diabetic patients that had been prescribed other diabetes medications.

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In 2011, a study found that patients taking DPP-4 inhibitors, such as Onglyza®, had 2.7 times more instances of pancreatic cancer than patients on other diabetes medications. Although type 2 diabetes puts patients at risk for developing pancreatic cancer, medications such as Onglyza® significantly increase these risks.

Symptoms of Acute Pancreatitis

A patient suffering from acute pancreatitis may suffer from a variety of symptoms. It is important to seek medical treatment for a proper diagnosis and to prevent the condition from becoming worse. Symptoms of acute pancreatitis may include:

  • Pain in the upper abdomen that radiates to the back
  • Swollen or tender abdomen
  • Nausea and vomiting
  • Fever
  • Increased heart rate

Diagnosis of Acute Pancreatitis

Acute pancreatitis is most commonly diagnosed with a blood test that measures the levels of the enzymes amylase and lipase. In some cases, additional tests may be required to make a diagnosis, including:

  • A pancreatic function test
  • A glucose tolerance test to measure the severity of damage to insulin-making cells
  • An ultrasound, MRI, or CT scan to view any inflammation or other visible problems
  • An x-ray to view the pancreatic and bile ducts
  • A biopsy of the pancreatic tissue

Treatment for Acute Pancreatitis

The pain associated with acute pancreatitis can be so severe that patients frequently go to the emergency room for treatment. The condition is typically treated with IV fluids and pain medication. Patients whose pancreatitis is more severe may be admitted to the hospital’s intensive care unit (ICU) so that doctors can monitor them for any damage to the heart, lungs, or kidneys. Severe pancreatitis can result in the death of pancreatic tissue, which can require surgical removal.

Litigation against Onglyza® Manufacturers

Hundreds of patients are filing lawsuits against the drug manufacturers AstraZeneca and Bristol-Myers Squibb for their failure to include adequate warnings about the risks of pancreatitis associated with Onglyza® and other similar drugs, such as Januvia or Kombiglyze™ XR.

The pain associated with acute pancreatitis can be so severe that patients frequently go to the emergency room for treatment.

The majority of these lawsuits have been consolidated into multidistrict litigation (MDL). This type of lawsuit, which is similar to a class action, allows for a combined evidence discovery process, but allows each plaintiff to retain their own counsel and make their own decisions concerning their case.

Other Complications and Side Effects Associated with Onglyza®

A safety review of Onglyza® and similar DPP-4 inhibitor medications by the FDA has found that these drugs cause an increased risk of heart failure, especially in patients who already suffer from existing heart or kidney disease. Symptoms of heart failure include:

  • An abnormal shortness of breath during routine activities
  • Difficulty breathing when lying down
  • Fatigue, tiredness, lethargy, muscle weakness
  • Weight gain that is accompanied by swollen ankles, feet, legs, or abdomen

Other risks and complications associated with Onglyza®, in addition to the risk of pancreatitis and pancreatic cancer, include:

  • Increased risk of respiratory and urinary tract infections (UTI)
  • High blood pressure
  • Headaches
  • Anemia
  • Severe joint pain
  • Depression
  • Fatigue

Find an Onglyza® Attorney Near You

If you or a loved one has suffered from pancreatitis, has developed pancreatic cancer, or any other severe complications or side effects after taking Onglyza®, you may be entitled to financial compensation. Please contact an experienced pharmaceutical attorney to schedule a complimentary case evaluation.

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