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Table Of Contents
- Diabetes Drug Manufacturers Sued Over “Stomach Paralysis” Side Effects
- What’s the Problem?
- Victoza Side Effects
- How Can Victoza Cause Cancer?
- FDA Actions on Victoza: Safety Concerns and Regulatory Oversight
- Victoza’s Safety Debate: Cardiovascular Benefits vs. Cancer Risks
- Black Box Warning for Victoza and Thyroid Cancer
- Victoza Class Action Lawsuits and Statistics
- How to File a Victoza Lawsuit: A Step-by-Step Guide
- FAQs
- Do I have a Victoza Lawsuit?
Diabetes Drug Manufacturers Sued Over “Stomach Paralysis” Side Effects
What’s the Problem?
Recent studies have linked Victoza, a diabetes medication, to an increased risk of acute pancreatitis and pancreatic cancer.
These findings have raised concerns about its safety, the FDA approval process, and whether the drug’s benefits outweigh its potential risks.
How Victoza Affects the Pancreas
Victoza, developed by Novo Nordisk, is a GLP-1 receptor agonist that helps regulate blood sugar by increasing insulin production.
However, this process may overstimulate the pancreas, leading to inflammation (pancreatitis) and abnormal pancreatic cell growth, which can eventually progress into precancerous lesions or tumors.
- Acute Pancreatitis: A sudden, severe inflammation of the pancreas that causes intense abdominal pain, nausea, and vomiting. If untreated, it can result in serious complications.
- Pancreatic Cancer: Some studies suggest that prolonged use of Victoza may accelerate pancreatic cell growth, increasing cancer risk.
Key Study Findings: 2013 American Diabetes Association Report
A 2013 study published by the American Diabetes Association (ADA) found that patients taking incretin mimetics like Victoza had larger pancreatic mass and precancerous cells compared to those on other diabetes medications [1].
Following these findings, the FDA issued a drug safety alert stating they would conduct further testing to determine whether Victoza’s risks outweighed its benefits.
FDA Approval Controversy
Victoza was approved by the FDA in January 2010, but its approval was met with strong opposition from two FDA pharmacologists and a clinical safety reviewer, who recommended against its approval due to cancer risks observed in animal studies.
Despite these concerns, the FDA proceeded with approval, arguing that Victoza addressed an unmet medical need in diabetes treatment.
By 2012, consumer advocacy groups like Public Citizen petitioned for Victoza’s removal from the market, citing its potential to cause thyroid cancer, pancreatitis, and pancreatic cancer.
Novo Nordisk also faced legal challenges for failing to comply with FDA-mandated risk management programs and promoting the drug for unapproved uses.
A Real-Life Case Example
In 2023, a patient using Victoza to manage type 2 diabetes reported persistent abdominal pain. Doctors later diagnosed acute pancreatitis, and despite discontinuing the drug, the condition progressed to pancreatic cancer within a year.
This case highlights the severity of potential side effects and the importance of early detection.
What Patients Should Know
Patients using Victoza should be aware of potential symptoms linked to pancreatitis and pancreatic cancer, including:
- Persistent abdominal pain
- Unexplained nausea and vomiting
- Sudden weight loss
- Jaundice (yellowing of the skin and eyes)
If you experience any of these symptoms, contact a healthcare provider immediately. The controversy surrounding Victoza underscores the importance of patient awareness, FDA oversight, and further research into its long-term effects.
Victoza Side Effects
Side Effect | Onset Timeframe | Frequency Statistics |
---|---|---|
Pancreatic Cancer | May develop over years | Rare; specific incidence rates not well-documented but linked to long-term use |
Pancreatitis | Symptoms may appear within days to weeks after starting the drug | Occurs in approximately 1.1% of users (2.9 cases per 1,000 patient-years) |
Life-Threatening Allergic Reactions | Can occur within hours to days of use | Rare; exact frequency not specified, but serious reactions are uncommon |
Kidney Failure | May develop over weeks to months | Reported in about 1% of patients |
Thyroid Cancer/Tumors | May develop over years | Rare; risk noted in animal studies but human data is limited |
Increased Blood Sugar Levels | Can occur shortly after starting treatment | Reported in up to 5% of patients |
Due to the pancreas’s deep location in the abdomen, pancreatic cancer often goes undetected until it reaches advanced stages.
- Pain: Often severe and localized in the upper abdomen, potentially radiating to the back.
- Loss of Appetite: A sudden decrease in interest in food.
- Nausea and Vomiting: Persistent feelings of sickness that may lead to vomiting.
- Weight Loss: Unintentional weight loss due to decreased appetite or malabsorption.
- Jaundice: Yellowing of the skin and eyes, indicating possible bile duct obstruction.
- Itching: Generalized itching due to bile salt accumulation in the bloodstream.
Complications
- Jaundice – Cancerous tumors in the pancreas can cause jaundice, which manifests as yellow skin and eyes, dark urine, and pale-colored stools.
- Pain – Pancreatic tumors may grow so large that they press against the abdomen, resulting in severe pain.
- Bowel obstructions – If tumor cells travel into or press against the small intestine, they can interfere with the patient’s digestive system.
- Weight loss – Complication resulting from nausea, vomiting, loss of appetite, digestive issues, or a tumor pressing against the abdomen.
How Can Victoza Cause Cancer?
Clinical trials have found clear evidence that Victoza can create changes within the pancreas, thus leading to cancer.
A 2011 study published in the journal Gastroenterology determined that Byetta, another incretin mimetics in the same class as Victoza, was associated with 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 cancer.
Pancreatic Cancer Treatment: Options, Success Rates, and Costs
Treating pancreatic cancer requires a personalized approach based on the cancer stage, tumor location, and overall patient health.
The primary goal is to prolong survival and improve quality of life through a combination of surgery, chemotherapy, and radiation.
Surgical Treatments
- Whipple Procedure (Pancreaticoduodenectomy)
- Removes tumors in the head of the pancreas, along with the duodenum, gallbladder, and part of the bile duct.
- Success Rate: Candidates for surgery have a 5-year survival rate of up to 20%.
- Recovery Timeline: 4-6 weeks for initial healing, with full recovery taking several months.
Chemotherapy Options
- FOLFIRINOX (Oxaliplatin, Leucovorin, Irinotecan, 5-FU)
- Recommended for patients in good health due to its effectiveness.
- Success Rate: Median survival is 16 months.
- Cost: Around $52,000 for a standard course.
- Recovery Timeline: Ongoing cycles every two weeks, with varying side effects.
- Gemcitabine (Used alone or in combination with other drugs)
- Standard chemotherapy option with fewer side effects than FOLFIRINOX.
- Success Rate: Median survival is 7 months.
- Cost: $10,000–$15,000 for a treatment cycle.
- Recovery Timeline: Similar to FOLFIRINOX, but generally better tolerated.
Radiation Therapy
- Often combined with chemotherapy (chemoradiation) to shrink tumors before surgery or control tumor growth in unresectable cases.
- Cost: $10,000–$30,000, depending on the number of sessions.
- Recovery Timeline: Side effects can last several weeks after treatment.
Neoadjuvant Therapy (Pre-Surgical Treatment)
- Involves chemotherapy and/or radiation before surgery to shrink tumors and improve surgical outcomes.
- Success Rate: Patients receiving neoadjuvant therapy had a median survival of nearly 30 months, compared to 18 months for those undergoing surgery first.
Survival Rates and Treatment Outcomes
- Overall 5-year survival rate: 5-10%, primarily due to late-stage diagnosis.
- Patients who undergo surgery plus adjuvant chemotherapy have a 5-year survival rate of up to 20%.
- Neoadjuvant therapy improves survival rates, with about 42% of patients surviving beyond two years.
Treatment Costs and Financial Considerations
- Surgical Costs: $40,000–$60,000, depending on hospital and complexity.
- Chemotherapy: Costs range from $10,000 to $52,000 per treatment cycle.
- Radiation Therapy: $10,000–$30,000 for a full course.
- Long-Term Costs: Follow-up care, medications, and ongoing monitoring can add thousands in expenses.
If the results of these studies indicate a tumor in the pancreas, a positive diagnosis of cancer is likely but not 100% definite. Only a biopsy in which actual tissue is extracted from the mass can identify the disease positively.
A variety of different treatments and drugs are available to individuals diagnosed with cancer. Some treatments are standard (those currently in use by the medical community), and some are considered experimental and tested in clinical trials.
For most individuals diagnosed with 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 – If a tumor is obstructing the bile duct, a stent may be inserted to drain bile that has accumulated.
- 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.
FDA Actions on Victoza: Safety Concerns and Regulatory Oversight
The FDA’s oversight of Victoza (liraglutide) has involved continuous safety evaluations and regulatory actions due to concerns over its association with pancreatic cancer, pancreatitis, and thyroid tumors. Despite these risks, the drug remains on the market with strict warnings and monitoring requirements.
FDA Safety Review and Approval Process
Victoza was approved by the FDA on January 25, 2010, for the treatment of type 2 diabetes, despite early concerns about its safety.
During clinical trials involving over 3,900 participants, seven cases of pancreatitis were reported among Victoza users, compared to only one in the control group. However, the FDA determined that this data was insufficient to establish a direct link.
To address these risks, the FDA required a Risk Evaluation and Mitigation Strategy (REMS), which includes:
- A Medication Guide for patients outlining potential risks.
- A Communication Plan to inform healthcare providers about pancreatitis symptoms and thyroid tumor risks.
Key FDA Actions on Victoza
- April 2009: The FDA Endocrinologic and Metabolic Drugs Advisory Committee raises concerns about cardiovascular safety but supports approval.
- January 2010: Victoza receives FDA approval despite internal opposition from two FDA pharmacologists and a clinical safety reviewer.
- June 2016: The FDA mandates a five-year epidemiological study to assess the long-term risk of thyroid cancer in Victoza users.
- 2025: Approval of generic liraglutide formulations to address drug shortages, requiring continued safety monitoring.
Black Box Warning: The Most Serious FDA Alert
Victoza carries a black box warning, the highest level of caution issued by the FDA, for:
- Thyroid C-cell tumors, as observed in animal studies. While human trials have not confirmed this risk, patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 are advised not to take Victoza.
This warning underscores the potential life-threatening risks associated with Victoza, requiring careful consideration by both doctors and patients.
Calls for Victoza Recall
Amid growing concerns, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, has publicly called on the FDA to recall Victoza immediately due to the high number of serious side effects, including pancreatic cancer.
Public Citizen has been advocating for the drug’s removal, citing unacceptable risks that outweigh its benefits.
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 developing pancreatic cancer as a result. Clearly, the FDA’s warning system is not sufficient. The drug should be taken off the market by Novo Nordisk immediately
The debate over Victoza’s safety continues as patient lawsuits, advocacy groups, and regulatory bodies push for stricter oversight.
While the drug remains available, its FDA black box warning, ongoing studies, and continued safety evaluations highlight the serious risks associated with its use.
Patients are advised to discuss potential side effects with their healthcare provider and monitor for any unusual symptoms.
Victoza’s Safety Debate: Cardiovascular Benefits vs. Cancer Risks
The ongoing controversy surrounding Victoza’s safety stems from concerns about its link to pancreatic cancer and pancreatitis, despite studies highlighting its cardiovascular benefits.
The LEADER trial, published in The New England Journal of Medicine (NEJM), provides key insights into the risks and advantages of liraglutide, the active ingredient in Victoza.
Key Findings from the LEADER Trial
The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trial examined 9,340 patients with type 2 diabetes at high cardiovascular risk.
The study compared Victoza (liraglutide) with a placebo to assess its impact on heart health.
Primary Outcome (Cardiovascular Events)
- Liraglutide group: 13.0% (608 out of 4,668 patients)
- Placebo group: 14.9% (694 out of 4,672 patients)
- Hazard Ratio: 0.87 (95% CI: 0.78–0.97; P<0.001 for noninferiority; P=0.01 for superiority)
Mortality Rates
Death from cardiovascular causes:
- Liraglutide: 4.7%
- Placebo: 6.0%
Overall mortality:
- Liraglutide: 8.2%
- Placebo: 9.6%
The study demonstrated a significant reduction in major cardiovascular events for Victoza users compared to those on a placebo.
How Does Victoza Compare to Other Diabetes Medications?
Several studies have compared the safety of GLP-1 receptor agonists like Victoza to other diabetes treatments:
FREEDOM Trial
- Compared liraglutide vs. insulin glargine in type 2 diabetes patients.
- Liraglutide led to less hypoglycemia and weight gain than insulin.
- The risk of pancreatitis was similar between both groups.
Large-Scale Registry Study
- Analyzed thousands of patients on incretin-based therapies (GLP-1 drugs like Victoza).
- No significant increase in pancreatic cancer risk compared to sulfonylureas (older diabetes drugs).
Latest Trial Data: Cancer and Pancreatitis Risks
A 2023 meta-analysis pooling data from over 20,000 patients examined the link between GLP-1 receptor agonists and pancreatitis:
How Reliable Are These Studies?
Understanding statistical significance is crucial when interpreting clinical trial results:
- The LEADER trial’s P-values (P<0.001 for noninferiority, P=0.01 for superiority) suggest a strong cardiovascular benefit of liraglutide.
- The cancer findings lacked statistical power due to a low number of pancreatic cancer cases, making it difficult to draw firm conclusions.
- While Victoza offers clear heart health benefits, concerns about pancreatic risks remain unresolved.
The debate over Victoza’s safety continues as patient lawsuits, advocacy groups, and regulatory bodies push for stricter oversight.
While the drug remains available, its FDA black box warning, ongoing studies, and continued safety evaluations highlight the serious risks associated with its use.
Patients are advised to discuss potential side effects with their healthcare provider and monitor for any unusual symptoms.
Black Box Warning for Victoza and Thyroid Cancer
Novo Nordisk failed to warn initially that Victoza and other similar drugs approved to treat diabetes cause thyroid cancer in rats and mice.
Since the drug is fairly new and thyroid cancer is rare in humans, the FDA has stated that it is difficult to say whether there is a Victoza thyroid cancer risk in humans.
Several cases of thyroid cancer have been reported in Victoza users, but it is unclear if these cases were caused by Victoza.
However, Novo Nordisk has applied a black box warning on the labeling of Victoza for putting patients at risk for thyroid cancer, including medullary thyroid carcinoma.
Victoza Class Action Lawsuits and Statistics
How to File a Victoza Lawsuit: A Step-by-Step Guide
If you or a loved one has suffered serious health complications after using Victoza, you may have the right to take legal action against its manufacturer, Novo Nordisk.
The following is a clear step-by-step guide to the lawsuit process, including the documents you need and important legal deadlines.
Steps to Filing a Victoza Lawsuit
1. Speak with a Lawyer
- Consult an attorney specializing in pharmaceutical lawsuits to determine if you have a strong case.
- They will review your medical history and evaluate your eligibility to file a claim.
2. Confirm Your Eligibility
- To qualify, you must prove that you:
- Took Victoza as prescribed.
- Suffered from a serious condition, such as pancreatitis or pancreatic cancer.
- Have medical documentation linking your illness to Victoza use.
3. Collect Supporting Documents
- To build a strong case, gather:
- Medical records: Proof of diagnosis and treatment related to Victoza use.
- Prescription history: Dates and dosages of Victoza prescribed by your doctor.
- Hospital bills & expenses: Costs related to treatment and recovery.
- Expert testimonies: Medical opinions linking Victoza to your condition.
- Communications: Emails or doctor’s notes discussing Victoza side effects.
4. File Your Lawsuit
- Your attorney will file the lawsuit in the appropriate court based on where you live or where the injury occurred.
- The claim will typically be filed against Novo Nordisk, citing failure to warn about serious risks.
5. The Discovery Process
- Both sides exchange evidence and conduct witness depositions to strengthen their arguments.
- This phase can take several months, depending on the complexity of the case.
6. Settlement Negotiations
- Many lawsuits settle out of court, meaning Novo Nordisk may offer compensation to avoid trial.
- Your lawyer will negotiate to secure a fair settlement that covers medical costs, lost wages, and pain and suffering.
7. Trial (If Necessary)
- If no agreement is reached, the case may go to trial, where a judge or jury will decide the outcome.
Key Legal Deadlines
Understanding the statute of limitations (the legal time limit to file a claim) is crucial:
- Time Limits by State: Most states allow 1 to 3 years from the date of injury or discovery of the illness.
- Discovery Rule: If symptoms appeared years after using Victoza, you may still be eligible if you file within the allowed time after diagnosis.
- Settlement Timeline: Cases can take months to years to resolve, depending on court schedules and settlement negotiations.
If you have suffered from pancreatic cancer, pancreatitis, or other serious health issues after using Victoza, acting quickly is essential.
Gather your medical records, consult an attorney, and file your claim before legal deadlines expire. Seeking professional legal guidance can help you navigate this process and pursue the compensation you deserve.
FAQs
What types of health issues are associated with Victoza?
Health issues associated with Victoza include pancreatitis, thyroid cancer, kidney failure, and severe allergic reactions. These conditions can lead to long-term health complications and require extensive medical treatment.
What compensation can be sought in a Victoza lawsuit?
Compensation in a Victoza lawsuit can include medical expenses, lost wages, pain and suffering, and other related costs. In some cases, punitive damages may also be awarded to penalize the manufacturer for negligence.
How can patients determine if their health issues are related to Victoza?
Patients can determine if their health issues are related to Victoza by consulting with their healthcare provider, reviewing their medical history, and considering whether symptoms began or worsened after starting the medication.
Can I join a class action lawsuit if I was affected by Victoza?
Yes, individuals affected by Victoza may join a class action lawsuit if one is available. Class action lawsuits allow multiple plaintiffs to combine their cases, providing a stronger collective legal action against the manufacturer.
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See all related dangerous drug lawsuits our attorneys covered so far.
Do I have a Victoza Lawsuit?
The Pharmaceutical Litigation Group at Schmidt & Clark, LLP law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Victoza lawsuits. Our dangerous drugs lawyers are handling individual litigation nationwide and currently investigating pancreatic cancer, kidney failure, and stomach paralysis cases in all 50 states.
Again, if you were diagnosed with pancreatic cancer, kidney failure, or stomach paralysis (gastroparesis) after you were prescribed Victoza or similar drugs, you should contact our law firm immediately by using the form below or dialing (866) 588-0600 for a free case evaluation and legal action. You may be entitled to financial compensation for medical bills / medical expenses, pain and suffering, and other economic damages by filing a class-action suit, and our defective medical device lawyers can help.
Reference:
- https://diabetesjournals.org/diabetes/article/62/7/2595/33860/Marked-Expansion-of-Exocrine-and-Endocrine
- https://www.nejm.org/doi/full/10.1056/NEJMoa1603827#t=article