Victoza, an injectable type 2 diabetes drug made by Novo Nordisk, has been linked to an increased risk for pancreatitis, pancreatic cancer and other serious side effects.
Free Confidential Lawsuit Evaluation: If you or a loved one developed pancreatic cancer after taking Victoza, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: LEADER Trial Finds Increased Rate of Pancreatic Cancer with Victoza
A June 2016 study published in the New England Journal of Medicine (NEJM) designed to assess the cardiovascular safety of Victoza found an increased risk of pancreatic cancer in patients treated with the drug. Specifically, pancreatic cancer occurred in 13 Victoza users compared to 5 patients treated with placebo. Given that the drug has been previously associated with pancreatitis, the new findings seem to reinforce the link between Victoza and pancreatic cancer, according to the researchers.
What’s the Problem?
Manufactured by Novo Nordisk, the Victoza pen was approved by the U.S. Food & Drug Administration (FDA) in January 2010 for the treatment of type 2 diabetes. The drug works by increasing the amount of insulin the body produces. However, the FDA’s approval of Victoza came against the advice of two reviewing pharmacologists and a clinical safety review.
In her statement against the approval of Victoza, clinical safety reviewer Dr. Karen Mahoney stated that “The clinical safety reviewer does not recommend approval of liraglutide at this time … In the United States, there are already 11 classes of drugs approved for glycemic control in type 2 diabetes … The need for new therapies for type 2 diabetes is not so urgent that one must tolerate a significant degree of uncertainty regarding serious risk concerns.”
Victoza Side Effects
Victoza has been linked to the following serious side effects:
Victoza & Pancreatitis
In addition to being linked to thyroid cancer, Victoza was also associated with a 3.7-fold increased risk of pancreatitis when compared to other diabetes drugs. In less than two years on the market, 200 patients being treated with Victoza were diagnosed with acute pancreatitis. Due to the fact that only about 10% of cases are ever reported to the FDA’s Adverse Event Reporting System (AERS), potentially as many as 2,000 people have contracted pancreatitis as a result of taking Victoza. Signs and symptoms of pancreatitis include:
- clammy skin
Pancreatitis is a known precursor to full-blown pancreatic cancer. A March 2013 study published in the journal Diabetes found that users of incretin mimetics like Victoza are more likely to have increased pancreatic mass and precancerous cells, which may eventually evolve into tumors or pancreatic cancer. Earlier that month, the FDA issued a drug safety communication stating that they were evaluating the study’s data and plan to conduct additional testing on the samples collected by researchers to further review the potential pancreatic toxicity associated with incretin mimetics like Victoza.
Due to a growing number of post-marketing reports linking Victoza to severe kidney damage, the FDA has required Novo Nordisk to include a warning on the drug’s label about “acute renal failure and worsening of chronic renal failure.” This condition occurs when the kidneys stop working. The kidneys remove waste products and help balance water, salt, and other minerals in the blood. When these organs fail, waste products, fluids, and electrolytes cannot be processed and build up in the body. Symptoms of renal failure may include:
- decreased urine output
- fluid retention
- swelling in the legs, ankles or feet
- shortness of breath
- seizures or coma
- chest pain or pressure
In addition to these complications, the FDA has required Novo Nordisk to add yet another warning to Victoza labels about serious allergic reactions that may require immediate medical intervention. Nearly 10% of patients treated with Victoza in clinical trials had antibodies to the drug, resulting in the following adverse reactions:
- increased infections (especially upper and lower respiratory tract)
- injection site reactions
- joint pain
- gastrointestinal events
All of these side effects were at least two times higher in Victoza users than patients being treated with other diabetes drugs. Side effects involving abdominal pain are especially serious because they may mask the symptoms of kidney failure and pancreatitis.
Public Citizen to FDA: Recall Victoza Now
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, believes that when considering the high number of serious side effects that have been linked to Victoza, the drug should be pulled off the market immediately.
“The FDA’s frequent solution to serious safety issues identified with new drugs is reckless: The agency simply describes the risks in the drug label and hopes that physicians and patients will pay attention. But more and more people are taking this drug, and more people are experiencing serious health problems as a result. Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market.”
Do I have a Victoza Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Victoza lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you got pancreatic cancer from Victoza, you should contact our law firm immediately. You may be entitled to compensation by filing a class action suit and our lawyers can help.