What’s the Problem?
Recent studies suggest that Victoza may increase the risk of serious side effects such as pancreatic cancer.
Pancreatitis is a known precursor to full-blown pancreatic cancer. A 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.
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:
- pancreatic cancer
- life-threatening allergic reactions
- kidney failure
How Can Victoza Cause Pancreatic Cancer?
Clinical trials have suggested that Victoza can create these changes within the pancreas, thus leading to pancreatic cancer.
A 2011 study published in the journal Gastroenterology determined that Byetta (another incretin mimetic in the same class as Victoza) was associated with a 2.9 times increased risk of pancreatic cancer. Peter Butler, one of the authors of the study, has called for additional research to better understand the link between incretin mimetics and pancreatic cancer.
“The data we have so far makes the question sufficiently robust that it has to be answered,” Butler stated. “Hopefully this debate will raise the awareness of the scientific community so that people will be motivated to join in the research.” Edwin Gale, an endocrinologist at the University of Bristol, UK, agreed with Butler, pointing out that “Pancreatitis may be just the tip of the iceberg, and it’s the iceberg that concerns me.”
Pancreatic cancer is relatively rare as far as cancers go, but is one of the most aggressive forms of the disease; most people survive less than two years after being diagnosed. Nearly 45,000 people are diagnosed with pancreatic cancer each year in the U.S., and about 38,000 will die from the disease. Studies have shown that patients with pancreatic cancer may have an increased risk for diabetes, but it’s unclear how diabetes – and the medications used to manage it – may have the potential to cause pancreatic cancer risks in previously cancer-free people.
Victoza Pancreatic Cancer Symptoms
Due to the fact that the pancreas lies deep in the abdomen in front of the spine, pancreatic cancer often goes undetected until its later stages. Once the tumor grows large enough to press on other nearby structures such as nerves, symptoms of pancreatic cancer may include:
- Loss of appetite
- Weight loss
- Jaundice (yellowing of the skin and eyes)
Symptoms of pancreatic cancer are generally the same in both men and women. Once the tumor metastasizes and sheds cancer cells into the blood and lymph systems, additional symptoms may occur depending on the location of the metastasis. Frequent sites of metastasis for pancreatic cancer include the liver, lymph nodes, and lining of the abdomen. Unfortunately, most pancreatic cancers are diagnosed only after the disease has traveled beyond the pancreas, or has metastasized to other areas of the body.
Pancreatic Cancer Treatment
Treatment options for individuals with pancreatic cancer depend on the stage and location of the tumor(s), as well as the patient’s age, overall health, and preferences. The primary goal of treatment is to destroy the tumors and eliminate the disease. When this isn’t possible, treatment becomes aimed at preventing cancer from migrating to other areas of the body and causing more harm. In terminal stages where treatment is no longer effective, palliative care may be implemented to make the patient as comfortable as possible.
Tests & Diagnosis
In patients suspected of having pancreatic cancer, a number of tests may be performed to confirm the diagnosis. These examinations may include ultrasound photographs, dye injections into the pancreatic duct, and tissue biopsies. If pancreatic cancer is confirmed, the patient will be treated according to the stage and type of the disease.
To identify the cause of symptoms, the patient’s doctor will take a comprehensive medical history and ask detailed questions about the nature of the illness, such as the time of onset, nature and location of pain, and other medical concerns. A physical exam will then be conducted to feel for a mass in the abdomen and swollen lymph nodes in the neck, jaundiced skin, or weight loss. Lab and imaging tests may also be ordered, which will show evidence that bile flow is being obstructed or other characteristic abnormalities.
If the results of these studies indicate a tumor in the pancreas, a positive diagnosis of pancreatic cancer is likely, but not 100% definite. Only a biopsy in which actual tissue is extracted from the mass can identify the disease positively. If pancreatic cancer seems very likely, and the tumor appears removable by surgery, doctors may recommend surgical intervention without a biopsy.
A variety of different treatments and drugs are available to individuals diagnosed with Victoza pancreatic cancer. Some treatments are standard (those currently in use by the medical community), and some are considered experimental and being tested in clinical trials. Which treatment a patient chooses depends on the stage and location of the disease, as well as his or her overall health and personal preferences.
For most individuals diagnosed with pancreatic cancer, the primary method of treatment is to surgically remove the tumor. However, if cancer has spread to other parts of the body and cannot be removed, the following types of palliative care may be implemented to relieve symptoms:
- Surgical biliary bypass – If a tumor is obstructing the small intestine and bile is accumulating in the gallbladder, a biliary bypass operation may be performed. During the procedure, the gallbladder or bile duct is cut and sewn into the small intestine to create a new path around the obstructed area.
- Endoscopic stent placement – In the event that a tumor is obstructing the bile duct, a stent may be inserted to drain bile that has accumulated. The stent may be placed through a catheter that drains to the outside of the body, or it may be positioned to go around the obstructed area and drain into the small intestine.
- Gastric bypass surgery – If a tumor is obstructing the flow of food, the stomach may be sewn directly to the small intestine so the patient can continue eating normally.
Non-surgical treatment options for individuals diagnosed with pancreatic cancer may include:
- Radiation therapy – involves using high-energy x-rays or other forms of radiation to eliminate cancer cells or keep them from migrating to other parts of the body. There are two separate and distinct varieties of radiation therapy. External radiation therapy uses a machine outside the body to concentrate radiation toward the tumor(s). Internal radiation involves a radioactive substance that is placed directly into or near cancer via needles, wires, or catheters. Whether a patient receives internal or external radiation therapy depends on the stage and type of cancer.
- Chemotherapy – Uses a cocktail of medications to eliminate cancer cells, either by destroying them or by stopping them from multiplying. When drugs are taken orally or via injection into a vein or muscle, they can reach cancer cells throughout the patient’s body. This is referred to as systemic chemotherapy. When the drugs are injected directly into the cerebrospinal fluid, an organ, or a body cavity, they mainly work against cancer cells in those areas. This approach is called regional chemotherapy.
- Biologic therapy – Uses the patient’s own immune system to fight cancer. Naturally-made or synthetic substances are used to boost, direct, or enhance the body’s natural defenses against the disease. This method of treatment is also commonly referred to as biotherapy or immunotherapy.
Complications of pancreatic cancer may include:
- Jaundice – Cancerous tumors in the pancreas can cause jaundice, which manifests as yellow skin and eyes, dark urine, and pale-colored stools. To treat the condition, a stent may be inserted into the bile duct to keep it open. If this is ineffective, surgery may be necessary to create a new path for bile to travel from the liver to the intestines.
- Pain – Pancreatic tumors may grow so large that they press against the abdomen, resulting in severe pain. This complication may be treated with pain medications, radiation therapy, or, in severe cases, alcohol injections into the nerves that control pain in the abdomen.
- Bowel obstructions – If tumor cells travel into or press against the small intestine, they can interfere with the patient’s digestive system. This can be treated with a stent to hold the small intestine open, or with bypass surgery to connect the stomach to a portion of the intestines that aren’t blocked.
- Weight loss – Complication resulting from nausea, vomiting, loss of appetite, digestive issues, or a tumor pressing against the abdomen. Pancreatic enzyme supplements may be prescribed to help with digestion, and patients may be advised to add extra calories to their meals.
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.”
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 a 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.
Victoza Class Action Lawsuits
Although we are a nationally recognized class action firm, the Pharmaceutical Litigation Group at our law firm has decided against the filing of a Victoza class action suit and is currently filing individual claims on behalf of injured individuals and/or their family members that have been diagnosed with pancreatic cancer after taking Victoza.
A class action is a type of lawsuit filed with the court on behalf of a large group of people or “class” of individuals that have been injured or wronged. The class is represented by the law firm and the case is generally decided upon a single member of the class who is sometimes referred to as the “class representative or class rep.”
Why Our Victoza Lawyers Are Filing Individual Lawsuits
In some instances, a class action may offer some advantages, as they aggregate a large number of individualized claims into one representational lawsuit. The aggregation can increase the efficiency of the legal process, lower the costs of litigation, and in some cases offer the solution to a common problem wherein small recoveries do not provide the incentive for any individual or law firm to file an individual lawsuit.
However, a class action suit can also be a detriment to many class members, as they are often forced into a blanket “low ball settlement” and higher attorney fees.
At Schmidt & Clark, LLP we understand that our clients are suffering emotionally and economically due to loss of wages and/or high medical bills and we plan to maximize each client’s recovery by filing individual Victoza lawsuits on their behalf.
Do I have a Victoza Lawsuit?
The Pharmaceutical 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.
Again, if you got pancreatic cancer from Victoza, you should contact our law firm immediately by using the form below or dialing (866) 588-0600. You may be entitled to compensation by filing a class-action suit and our lawyers can help.