Every cell in the human body relies on glucose for proper function, a crucial process facilitated by the hormone insulin. However, in type 2 diabetes, the body’s response to insulin diminishes, leading to insufficient insulin production by the pancreas.
Excessive body weight exacerbates this condition by increasing the demand for insulin. If left unchecked, this can result in significant health complications.
To manage type 2 diabetes, the drug Victoza is widely prescribed. The drug has recently faced several lawsuits due to claims of severe side effects and claims that patients were not adequately warned about these risks.
These allegations have initiated Victoza pancreatic cancer lawsuits against Novo Nordisk, the pharmaceutical company behind Victoza, raising concerns among patients regarding the safety of this diabetes medication.
In this blog, we delve into the overview of Victoza, its side effects, and the reasons behind people filing Victoza lawsuits.
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What is Victoza?
Victoza (generic name: liraglutide) is a medication belonging to a class called GLP-1 receptor agonists. It works by mimicking the effects of a hormone called glucagon-like peptide-1 (GLP-1), which helps regulate blood sugar levels by stimulating insulin secretion and reducing glucose production in the liver.
Victoza is an FDA-approved injectable drug used to help lower blood sugar levels in adults with type 2 diabetes who are 10 years of age or older. In some cases, Victoza promotes weight loss.
Novo Nordisk manufactures Victoza, which is intended to assist patients in achieving glycemic control when paired with a specific diet and exercise regimen.
Additionally, it has been licensed to reduce the risk of cardiovascular events in individuals with diabetes and cardiovascular disease, including peripheral artery disease and coronary artery disease.
Victoza can be administered once daily. It is injected subcutaneously, or beneath the skin, using an injector pen. There are 18 milligrams of liraglutide in each pen.
Side Effects of Victoza
Victoza has been linked to several serious side effects, including
- Pancreatitis
- Pancreatic cancer
- Thyroid cancer
- Gallbladder problems
From 2010 to September 30, 2019, 30,740 reports of adverse events linked to the medicine were made to the U.S. Food and Drug Administration’s Adverse Events Reporting System (FAERS). There were 10,967 serious cases total in this period, 917 of which resulted in death.
Victoza and Pancreatitis
A study has shown concerns have arisen about a link between GLP-1 receptor agonist medication and pancreatic issues, including inflammation and pancreatitis.
Animal studies have indicated possible harm to pancreatic tissue from these drugs. Clinical studies have shown elevated levels of amylase or lipase in patients taking GLP-1 receptor agonists, suggesting potential pancreatic damage.
However, other studies have failed to show a significant association between these medications and pancreatitis risk.
A 2015 study analyzed data from Novo Nordisk-sponsored trials involving liraglutide, comparing it with other active comparators. The study examined the safety of incretin-based therapies, particularly focusing on the incidence of acute pancreatitis.
The findings, indicating an increased incidence of acute pancreatitis with liraglutide compared to other treatments. This was primarily due to the limited number of cases and the presence of various confounding factors.
Additionally, not all reported cases met the established diagnostic criteria for acute pancreatitis.
Regulatory agencies like the FDA and EMA have reevaluated extensive data and concluded that concerns about a direct link between GLP-1 receptor agonists and pancreatitis are not supported by current evidence.
While no definitive cause-and-effect relationship has been established, caution may be warranted when prescribing these medications to patients with certain risk factors for pancreatitis.
Pancreatitis symptoms are:
- Fever
- Rapid pulse
- Vomiting and nausea
- Swollen abdomen
- Abdomen pain
Victoza and Pancreatic Cancer
Pancreatitis and pancreatic cancer have been reported in certain people treated with Victoza and other incretin-mimetic diabetic medications. Several studies have raised concerns about the link between Victoza, an incretin mimetic used to treat type 2 diabetes, and an increased risk of pancreatic cancer.
Research indicates that patients using Victoza may be three times as likely to develop pancreatic cancer compared to those not using the drug.
A 2013 study published in the Diabetes Journal shows that in patients with type 2 diabetes treated with incretion therapy (DM-I), pancreatic mass increased by approximately 40% compared to those with diabetes not treated with such drugs.
Additionally, the pancreatic fractional insulin area was approximately fivefold higher in DM-I patients compared to individuals not receiving incretin therapy. Increased pancreatic mass and precancerous cells, which may potentially develop into tumors or pancreatic cancer.
Novo Nordisk’s own clinical trials revealed common side effects such as upper respiratory infections and gastrointestinal problems, but more serious concerns emerged regarding the potential for pancreatic cancer and thyroid tumors.
While the FDA has not definitively concluded the connection between Victoza and pancreatic cancer, it has issued warnings about the risks of acute pancreatitis and thyroid tumors.
Symptoms of pancreatic cancer include
- Stomach pain
- Back pain
- Weight loss
- Jaundice
- Blood clot
- Pancreatitis
- Vomiting and nausea
Victoza and Thyroid Cancer
Prior to the FDA approval, safety studies conducted on mice and rats revealed that Victoza could induce malignant tumors in the thyroid gland and develop medullary thyroid cancer, even at normal exposure levels.
In human studies, patients taking Victoza showed a higher incidence of papillary thyroid cancer and thyroid C-cell hyperplasia compared to those using other diabetes medications.
However, due to the rarity of thyroid cancer and the time it takes for cancer to develop, the studies are not yet large or long enough to accurately estimate the risk of Victoza-induced thyroid cancer. Further research and data collection are necessary to better understand this potential risk.
Consequently, the FDA mandated Novo Nordisk to issue warnings to doctors regarding the potential risk of thyroid cancer associated with Victoza and to monitor cases of thyroid cancer over 15 years.
Thyroid cancer symptoms include:
- Neck pain
- A lump in the neck
- Trouble swallowing
- Constant cough
- Difficulty breathing
- Voice changes, such as hoarseness
Victoza and Gallbladder Problems
Victoza’s drug label warns of the risk of acute gallbladder disease based on clinical trials where 3.1% of patients who took Victoza experienced this condition compared to 1.9% of those on placebo.
A 2018 study in Diabetes, Obesity and Metabolism aimed to compare the effect of liraglutide at doses of 0.6 mg and 3.0 mg with a placebo on gallbladder emptying in adults with a BMI of ≥27 kg/m2 and without diabetes.
Participants were randomized to receive either liraglutide or placebo, with gradual dose escalation over 12 weeks. The primary endpoint was the maximum postprandial gallbladder ejection fraction (GBEFmax) at 12 weeks.
Results showed that liraglutide treatment did not significantly affect gallbladder ejection fraction compared to placebo. However, it appeared to prolong the time to GBEFmax. The most commonly reported adverse events were gastrointestinal disorders, particularly nausea and constipation.
Studies also indicate an increased risk of gallstone production with Victoza use.
However, some critics point out limitations in trial duration and potential biases due to manufacturer funding.
Gallbladder problems symptoms include
- Abdominal pain
- Jaundice
- Changes in bowel movements
- Heartburn or chest pain
- Nausea and vomiting
FDA Warning on Victoza
About 200 adverse complaints were sent to the FDA in the first seventeen months after Victoza’s FDA approval; the actual number was probably much higher, as it is commonly acknowledged that only 10% of consumers will report adverse health occurrences to the FDA.
The U.S. Food and Drug Administration (FDA) said in a statement released in March 2013 that it was reviewing new research indicating a higher risk of pancreatitis and precancerous cellular alterations known as pancreatic duct metaplasia in type 2 diabetes patients on Victoza.
The FDA urged medical professionals and patients to notify the agency of any adverse drug-related incidents.
After two years, Novo Nordisk received a letter from the FDA recommending that the drug label for Victoza include a warning about the possibility of thyroid cancer. Following that, Novo Nordisk added the strongest medication warning, known as a “Black Box Warning,” to the label of Victoza, indicating that liraglutide can result in thyroid C-cell malignancies.
The risk of thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), a rare and challenging-to-treat form of thyroid cancer, is included in the black box warning for Victoza.
The medication’s manufacturer issued the warning because animal studies demonstrated that liraglutide exposure resulted in tumor development in mice; however, it is unclear how this may impact humans.
Between 2010 and September 30, 2019, more than 250 reports of different thyroid malignancies in Victoza users were received by FAERS; among them were 27 cases of MTC, which resulted in two fatalities.
History of Victora Lawsuits
The Judicial Panel on Multidistrict Litigation moved 53 cases involving Januvia, Janumet, Byetta, and Victoza drugs to MDL No. 2452 in August 2013.
The court believed that centralizing these cases would be more efficient because all of the claims alleged the medications caused pancreatic cancer and pancreatitis.
The U.S. Judicial Panel on Multidistrict Litigation consolidated these cases in California federal court under the title In Re: Incretin Mimetics Products Liability Litigation.
Defendants argued that the FDA wouldn’t have approved a label warning for pancreatic cancer, invoking preemption. In November 2015, U.S. District Judge Anthony J. Battaglia granted the defendants’ request to dismiss all cases in the MDL, citing the concept of preemption.
He ruled that failure-to-warn claims were void because there was clear evidence that the FDA would not have approved a label warning for pancreatic cancer, thus shielding the drug makers from liability. Battaglia also disqualified the plaintiffs’ expert witness and denied additional discovery.
Following a dismissal by the trial judge, all cases were reinstated by the Ninth Circuit Court of Appeals in 2017. The appeals court ruled that the judge had restricted plaintiffs’ ability to gather evidence and improperly disqualified an expert witness.
Victoza Lawsuit Update 2024
Victoza and other incretin mimetics are still prescribed to millions of Americans with type 2 diabetes, and the corporations that make them insist that the medications are safe. Because these medications generate enormous profits for the pharmaceutical firms, there is concern that the businesses are putting profit over people.
It’s essential for patients to educate themselves about the potential side effects of Victoza and to report any adverse reactions to their doctors promptly.
Victoza Lawsuit Settlements
Novo Nordisk has agreed to pay $58.65 million to settle allegations by the U.S. Department of Justice and seven whistleblowers that it misled doctors about the risks associated with Victoza. The settlements cover violations of the False Claims Act and the federal Food, Drug and Cosmetic Act from 2010 to 2014.
The company denies wrongdoing but aims to refocus on developing medicines while emphasizing its commitment to transparent communication with healthcare professionals.
Federal authorities allege that Novo Nordisk failed to adequately inform physicians about the potential risk of a rare form of cancer when marketing Victoza. Despite requirements from the FDA, the company’s sales representatives allegedly provided misleading information, leading to some doctors being unaware of the risks.
This settlement reflects the Department of Justice’s efforts to ensure drug manufacturers comply with regulations and provide accurate risk information to medical professionals and patients.
This is not the first time Novo Nordisk has faced issues with federal authorities. In the past, the company has been fined for illegal promotion of other drugs and for making improper payments to the former Iraqi government.
Allegations against Novo Nordisk
Lawsuits regarding Victoza injuries have been filed nationwide on behalf of individuals who were prescribed Victoza and later experienced pancreatitis, pancreatic cancer, or other side effects.
Victoza cancer lawsuits have been filed against Novo Nordisk, alleging negligence, failure to warn, and misleading marketing practices. Plaintiffs claim that the company prioritized profits over patient safety and failed to conduct sufficient studies to assess the long-term risks associated with Victoza use.
It is the responsibility of manufacturers to warn consumers about any risks connected to their products. Plaintiffs contend that Novo Nordisk should have warned customers about the higher risk of pancreatic cancer associated with Victoza, but did not.
The plaintiffs contend that if they had received the appropriate warning, they would never have used Victoza in the first place.
Are you Eligible to File a Victoza Lawsuit?
To be eligible to file a Victoza lawsuit, individuals must have suffered harm or injury as a result of using Victoza. It’s essential to have medical records, prescriptions, and other relevant documentation that can support the claim. LezDo TechMed can help you review medical records and demonstrate the link between Victoza use and the harm you suffered.
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If you believe you have been harmed by Victoza, it’s advisable to seek legal advice and explore options for pursuing compensation. Attorneys can evaluate your case, provide legal advice, and represent your interests throughout the legal process.
You can receive compensation for damages like medical expenses, pain and suffering, and other damages resulting from their use of the medication. Utilizing the evidence collected, your Victoza lawsuit attorney will strive to secure compensation for the losses you’ve experienced due to your injuries.
To conclude,
While medications like Victoza can help people manage their diabetes and restore energy levels, it’s important to recognize that not all diabetic drugs are without risks. It’s crucial for individuals to carefully read and understand the labels of their medications to be aware of potential side effects and take necessary precautions.
