Januvia, Byetta and Victoza

CaseyGerry has a long history in drug litigation. Our attorneys are not currently accepting new clients for this case.  

Januvia, Byetta and Victoza are incretin-mimetic medications, and are used — along with diet and exercise – to lower blood sugar in adults with type 2 diabetes.

The drugs help control blood sugar levels by mimicking the incretin hormones that the body produces naturally to stimulate the release of insulin in response to a meal. FDA Report

However, researchers have found that these drugs may have harmful effects on the pancreas. In fact, a UCLA study provides evidence of increased pre-cancerous changes in diabetic patients using incretin-mimetics. Bloomberg Report

The concern is that the drugs work by increasing levels of glucagon-like peptide-1, a hormone which may accelerate precancerous conditions already present in middle-aged people. New York Times Story

Lawsuits related to these medications have been filed in seven federal judicial districts, including the Southern District of California, the District of Arizona, and the District of Colorado, and various state courts. All of the lawsuits involve allegations that the manufacturers of the medications failed to provide patients and doctors with adequate warnings about the risks of pancreatic cancer, thyroid cancer and pancreatitis.

In response to the increasing number of lawsuits related to the drugs, the Judicial Panel on Multidistrict Litigation recently ordered that dozens of Januvia, Byetta and Victoza lawsuits be consolidated in the Southern District of California.

While the panel noted that it is unusual to consolidate lawsuits involving competing drug companies, it determined that the manner in which the drugs manage blood insulin levels and pancreatic cancer allegations were similar enough to merit consolidation.

The Warning

Since these drugs were approved, multiple warnings have been issued by the FDA www.fda.gov warning about potential complications. Concerns about pancreatic cancer surfaced in 2009, when the FDA ordered the manufacturer of Januvia to include a warning about its connection to pancreatitis.

Two years later, a study by Gastroenterology //www.gastro.org/journals-publications/gastroenterology raised the possibility that Januvia or Byetta may also cause serious side effects, such as pancreatitis and pancreatic cancer. The study even found that Byetta (exenatide) may increase risk of thyroid cancer. When compared to other treatments, the researchers found a six fold increase of reported cases of pancreatitis (inflammation of the pancreas) linked to patients taking Januvia or Byetta; a 2.9-fold increase in reported cases of pancreatic cancer among those taking Byetta and a 2.7-fold increase of reported pancreatic cancers among Januvia users. USA Today Report

Additionally, examination of pancreases from 20 diabetics showed a 40 percent increase in pancreatic cells as well as cell damage in the people treated with incretin therapy. Of the 20 pancreases, eight were from people taking incretin therapy, while 12 were on other treatments, according to a study in Diabetes, the journal of the American Diabetes Association. Seven of the eight patients taking incretin therapies for a year or more were using Merck’s Januvia while the other was using Byetta. Bloomberg News Report

In the Spring of 2013, the U.S. Food and Drug Administration www.fda.gov posted safety information for patients and healthcare providers on: “Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication – Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas.”

CaseyGerry is investigating potential Januvia, Byetta and Victoza lawsuits lawsuit claims on behalf of individuals who allegedly developed pancreatitis, pancreatic cancer or thyroid cancer as a result of taking these Type 2 diabetes medications. If you or a loved one has concerns about the effect of these drugs, please contact a San Diego Pharmaceutical attorney at CaseyGerry for a free consultation and case review.

Byetta

Byetta – along with its longer-acting version Bydureon —  is a prescription injectable medicine used for treatment of type 2 diabetes, a condition in which a person is not producing enough insulin and as a result has high blood sugar.  Manufactured by Bristol-Myers, it is injected twice a day before meals to control the amount of sugar in the blood stream. //www.byetta.com/

Currently, the FDA is evaluating unpublished new findings from academic researchers that suggest a possible link between Byetta and risk of pancreatitis, pre-cancerous cellular changes and potential pancreatic toxicity. FDA Drug Safety

In addition to pancreatitis, Byetta has been associated with thyroid cancer.

Victoza

An injectable medication used daily for type 2 diabetes, Victoza is known generically as liraglutide. //www.victoza.com/

In addition to studies linking it to pancreatitis and pancreatic cancer, Victoza has been associated in animal studies to an increased risk of a rare thyroid cancer, according to the FDA.

In 2012, the public advocacy group Public Citizen //www.citizen.org/ filed a petition with the FDA requesting the agency remove Victoza from the market. Public Citizen cited the risk of thyroid cancer, pancreatitis, serious allergic reactions and kidney failure as outweighing any possible benefits to the drug. In a news release, Public Citizen noted that two FDA pharmacologists and an FDA clinical safety reviewer advised against approving Victoza.

Januvia

An oral antihyperglycemic, Januvia //www.januvia.com/ is a top selling drug manufactured by Merck and is either used alone or in combination with other oral antihyperglycemic agents, such as metformin. Medilexicon Information

It is a once a day prescription pill used for treatment of type 2 diabetes and may be prescribed with other diabetes medications. Like other incretins, Januvia has been linked to thyroid cancer and has been found to cause pancreatitis, which is linked with an increased risk of pancreatic cancer. USA Today Report on Pancreatic Cancer

Symptoms of Pancreatitis

Signs and symptoms of pancreatitis may vary, depending on which type you experience.

Acute pancreatitis signs and symptoms include:

• Upper abdominal pain
• Abdominal pain that radiates to your back
• Abdominal pain that feels worse after eating
• Nausea
• Vomiting
• Tenderness when touching the abdomen
• Chronic pancreatitis signs and symptoms include:
• Upper abdominal pain
• Indigestion
• Losing weight without trying
• Oily, smelly stools (steatorrhea)

Make an appointment with your doctor if you have persistent abdominal pain. Seek immediate medical help if your abdominal pain is so severe that you can’t sit still or find a position that makes you more comfortable. Mayo Clinic Health