Januvia, Victoza, Janumet & Byetta | Incretin Lawsuit
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Type 2 diabetes patients taking any of the drugs classified as Incretin Mimetics, such as Januvia, Victoza, Janumet, and Byetta, are potentially three times more likely to develop pancreatic cancer. Pancreatic cancer is a particularly aggressive form of cancer that most often receives a diagnosis in the later stages. If you or a loved one is suffering or suffered from pancreatic cancer as a result of these medications, contact The Carlson Law Firm. We have a qualified Incretin Lawsuit or Pancreatic Cancer Lawsuit Lawyer that can help you with your recovery.
The Carlson Law Firm has more than 40 years of experience representing clients who were victims of dangerous drugs. Potential cases are currently being evaluated on behalf of individuals throughout the United States. If you have suffered an injury caused by Janumet or Januvia, you may be entitled to compensation. The trial attorneys at The Carlson Law Firm can successfully represent you in your claim against clients the pharmaceutical company for negligence. Request a free consultation; there will be no cost to you unless we obtain a successful recovery.
What are Incretin Mimetics?
Incretin Mimetics are a group of drugs to treat Type 2 diabetes. Januvia, Victoza, Janumet, and Byetta are oral prescription pills or injectable medications used to help lower a diabetic patient’s glucose levels. The U.S. Food and Drug Administration (FDA) approved Januvia in 2006, and Janumet was approved in 2007.
What is the Basis of the Incretin Lawsuit?
According to court documents, Merck & Co. marketed these medications despite knowing that they were dangerous. Further, documents allege the company withheld important information about the risk of health problems causing pancreatic cancer and pancreatitis from Januvia and Janumet. Hundreds have taken legal action against the makers of these drugs for putting patients at an increased risk of developing life-threatening pancreatic cancer.
As a result, financial compensation may be available through an Incretin Cancer lawsuit for individuals diagnosed with:
- Pancreatic cancer
- Hemorrhagic or Necrotizing Pancreatitis
- Kidney failure
- Wrongful death
What is Type-2 Diabetes?
Type 2 diabetes is a condition in which blood glucose or sugar levels are too high. Normally when a person eats, the body will absorb sugar from the food and turn it into glucose, which is dissolved in the bloodstream. At the same time, the pancreas produces insulin which is a hormone that tells cells to stop using reserved energy and start absorbing glucose from the bloodstream. Individuals with type 2 diabetes have cells that are resistant to insulin and do not absorb enough sugar from the bloodstream causing high blood sugar levels. Januvia and Janumet are intended to help a person with type 2 diabetes control their blood sugar more effectively.
What is Januvia?
Sitagliptin, more commonly known as Januvia, was approved as the first in a new class of diabetes medications are known as dipeptidyl peptidase-4 (DPP-4) inhibitors. This medication was advertised as a once-daily prescription pill meant to help adults with type 2 diabetes lower their blood sugar levels. In September 2009, the FDA alerted healthcare professionals to monitor diabetic patients taking this drug for early signs of pancreatitis.
Merck allegedly failed to test Januvia properly and did not provide risk information to the FDA, healthcare professionals, and patients.
Januvia Side Effects
- Upper respiratory tract infections
- Common cold
- Diarrhea, Stomach pain
- Joint pain
- Kidney damage
- Low blood sugar
- Severe allergic reactions
- Acute pancreatitis (inflammation of the pancreas)
- Pancreatic cancer
What is Janumet?
Januvia and metformin combine to make Janumet. Janumet is for people with diabetes who do not gain glycemic control from just a single medication. Often, this prescription medication comes in a tablet form prescribed for use in addition to diet and exercise to lower blood sugar in adults with type 2 diabetes.
Janumet Side Effects
- Upper respiratory tract infections
- Gas and bloating
- Muscle pain
- Acute pancreatitis (inflammation of the pancreas)
- Hemorrhagic pancreatitis (bleeding in the pancreas)
- Necrotizing pancreatitis (death of pancreatic tissue)
- Pancreatic cancer
- Lactic acidosis
- Little or no urination
- Fever or a sore throat
- Severe skin reaction
Why does Janumet Carry an FDA Black Box Warning?
Janumet carries a black box warning, the FDA’s most serious type of warning because it contains metformin which may lead to lactic acidosis. Lactic acidosis a form of metabolic acidosis that begins in the kidneys. In patients with lactic acidosis, kidneys are unable to remove excess acid from their body.
Lactic acidosis is a side effect of metformin that begins in the kidneys. Individuals with lactic acidosis have kidneys that are unable to remove excess acid from their body. This condition causes a build-up of lactic acid in the body more quickly than the body can remove it. This causes acidity levels in the blood to spike. The buildup of acid causes an imbalance in the body’s pH level.
Signs of lactic acidosis are nausea and vomiting, dizziness, fatigue, feeling cold, muscle pain, slow or fast heartbeat, rapid breathing or shortness of breath, and a decreased appetite. Lactic acidosis is treatable. However, if left untreated it may be life-threatening.
Individuals with kidney, liver, or heart problems have a higher risk of suffering lactic acidosis.
What is Victoza?
Manufactured by Novo Nordisk, Victoza is a once-daily injection for the treatment of type 2 diabetes in adults to help lower blood sugar levels, along with diet and exercise. The generic name for Victoza is liraglutide.
The use of Victoza is associated with the risk of pancreatitis, as well as the risk of medullary thyroid cancer. The FDA is requiring Novo Nordisk to conduct a five-year epidemiological study and to create a medullary thyroid cancer registry to monitor cases related to Victoza use.
What is Byetta?
Byetta is an injectable prescription medicine that can help control blood sugar levels in adults with type 2 diabetes, in conjunction with diet and exercise. The manufacturer, Amylin Pharmaceuticals (Nasdaq: AMLN), markets Byetta as capable of lowering blood sugar levels and being safe to prescribe with other diabetic medications. The generic name for Byetta is exenatide.
Additionally, it has been alleged that Amylin Pharmaceuticals failed to test Byetta properly before bringing it to market. Further, the suit alleges that the company failed to provide adequate information to the FDA about the drug’s risks.
Incretin FDA Warnings
In 2009, the FDA issued a safety alert linking sitagliptin, the active ingredient in Januvia and Janumet with the development of acute pancreatitis. Pancreatitis is an inflammation of the pancreas causing the body’s digestive enzymes to attack the pancreas. For instance, the disease can cause tissue damage, infection, cyst formation, and bleeding. It can spread to other organs such as the heart and kidneys.
The FDA requested an update to the medications warning label in September 2009, requiring information about the link between Januvia and pancreatitis.
The FDA issued a letter to Merck in February 2012 over the failure to conduct required testing on the risk of pancreatitis from Januvia and Janumet side effects. Merck had stated they would be conducting a three-month study on Januvia’s pancreatic safety by June 2011, but they failed to follow through.
In March 2013, cases became worse when the FDA published a Drug Safety Communication for all incretin mimetic diabetes drugs, including Janumet and Januvia. The safety communication included study results revealing that the use of the medication may double the risk of hospitalization due to pancreatitis. Additionally, it can cause pre-cancerous cellular changes called pancreatic duct metaplasia, which may lead to pancreatic cancer.
In August 2015, the FDA issued a warning that type 2 diabetes drugs in the DPP-4 inhibitor class (Januvia and Janumet) can cause severe, disabling joint pain.
How do Januvia and Janumet Lead to Pancreatitis?
Pancreatitis cases associated with Januvia and Janumet tend to be acute. The disease occurs quickly, usually develops in less than two months and it can be fatal. In fact, between 2006 and 2009 there were nearly 100 cases reported to the FDA of acute pancreatitis caused by Januvia.
The pancreas is a sensitive organ which will become inflamed if under attack. Like all organs in the body, inflammation is our bodies immune response but long term, it can damage the organs instead of protecting them. The pancreas may perceive DPP-4 inhibitors as a threat and in some cases become inflamed. This condition is known as pancreatitis and is now understood these drugs can cause it even years after taking it.
An inflamed pancreas will start attacking itself with its own digestive enzymes. Eventually, this can end up destroying healthy cells and prevent the pancreas from producing necessary enzymes. Januvia increases the levels of pancreatic enzymes needed for digestion. The metformin in Janumet damages the cells storing the enzymes. Having a combination of increased enzyme levels and their release due to cell damage can lead to pancreatitis. Pancreatitis is a very painful condition that can be deadly and requires medical attention as soon as possible. In addition, it can come suddenly, or it can come slowly and be a long process.
Symptoms of Pancreatitis
- Upper abdominal pain
- Swollen and tender abdomen
- Nausea and vomiting
- Increased heart rate
Risk of Pancreatic Cancer After Taking Incretins
The American Cancer Society estimates that about 55,440 people will be diagnosed with Pancreatic cancer in 2018 and about 44,330 people will die because of it. This dangerous form of cancer is very difficult to diagnose, and the diagnosis is often made late in the course of the disease. Because of its mortality rate, early detection greatly improves a person’s chances of survival.
What Is Pancreatic Cancer?
Pancreatic cancer is an aggressive form of cancer that begins when abnormal cells within the pancreas grow out of control. The damages from pancreatitis can leave the pancreas vulnerable to pancreatic cancer because of an increase in cell division that occurs when the organ is inflamed. Many cases of pancreatic cancer are incurable and result in death.
Symptoms of Pancreatic Cancer
- Weight loss
- Loss of appetite
- Back pain
- Nausea and vomiting
- Discomfort in the upper part of the abdomen
Diagnosis of Pancreatic Cancer
Once your Doctor suspects Pancreatic Cancer, he or she will perform a number of diagnostic tests to determine whether the suspected cancer is present or not.
The procedures available include:
- Imaging: Ultrasound, computerized tomography (CT) scans, magnetic resonance imaging (MRI), or positron tomography (PET) scans. These tests help to visualize your pancreas.
- Endoscopic Ultrasound (EUS): An EUS is an ultrasound device used to make images of your pancreas from inside your abdomen. During this procedure, a scope is placed down your esophagus through a tiny, flexible tube and into your stomach where it can take images of your pancreas.
- Biopsy: A biopsy is a procedure to remove a small sample of tissue for examination under a microscope. Your medical team can obtain a sample of tissue from the pancreas by inserting a needle through your skin and into your pancreas, or a sample can be taken during and EUS procedure.
- Blood Tests: A blood test can be performed and the sample tested for tumor markers specific to pancreatic cancer cells.
Treatment of Pancreatic Cancer
Treatment for pancreatic cancer will vary depending on your diagnosed stage of cancer, as well as your overall health and wellness. Personal preferences are also heavily weighted in this decision. For the majority of pancreatic cancer sufferers, the first goal of pancreatic cancer treatment is to eliminate cancer, if and when possible. When elimination isn’t an option, the focus may be on improving your quality of life and preventing your pancreatic cancer from growing or causing further harm.
Pancreatic Cancer treatment options include:
- Clinical trials
- Supportive/Palliative care
Pancreatic cancer treatments may involve one of a combination of the above procedures.
Pancreatic cancer lawsuits are building across the U.S. Plaintiffs claim the type 2 diabetes drugs caused pancreatic cancer. Additionally, the lawsuits claim that the drugmakers failed to adequately warn users of serious risks. These risks include an increased risk of developing an often-fatal form of pancreatic cancer.
FDA Evaluating Rhabdomyolysis Risk
The FDA is currently evaluating new safety information and potential signals of serious risk linking DPP4 diabetes drugs and rhabdomyolysis. The FDA Adverse Event Reporting System (FAERS) identified this potentially life-threating kidney side effect between April and June 2017.
Rhabdomyolysis is the breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood. As a result, these substances are harmful to the kidney and have the potential of causing kidney damage.
The most recent FDA quarterly report issued in October 2017 informing consumers that the following 13 oral diabetes medicines are under investigation for this possible rhabdomyolysis side effect: Glyxambi (empagliflozin and linagliptin) tablets
- Janumet (sitagliptin and metformin hydrochloride) tablets
- Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets
- Januvia (sitagliptin) tablets
- Jentadueto (linagliptin and metformin hydrochloride) tablets
- Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets
- Kazano (alogliptin and metformin hydrochloride) tablets
- Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets
- Nesina (alogliptin) tablets
- Onglyza (saxagliptin) tablets
- Oseni (alogliptin and pioglitazone) tablets
- Qtern (dapagliflozin and saxagliptin) tablets
- Tradjenta (linagliptin) tablets
The drug manufacturer has placed their desire for profits before consumer safety by ignoring data and not warning consumers or the medical community.
The allegations raised in Januvia and Janumet lawsuits suggest Merck has:
- Failed to warn about potential side effects of Januvia and Janumet adequately
- Failure to warn physicians about the importance of monitoring for first signs of changes to the pancreas, which may have helped users identify chronic asymptomatic pancreatitis that ultimately led to cancer following Januvia or Janumet.
- Failed to issue a recall after dangers became clear from taking the prescription drugs
Patients took these prescriptions under the guise to better their lives. However, many now suffer from new health conditions such as pancreatic cancer in addition to their diabetes. While the intention of these drugs was to assist diabetic people, they have, in fact, put them in more danger. The treatment for the severe side effects from these drugs requires long-term medical care, and in some cases, hospitalization. Financial compensation will not undo all of the harm and injuries patients may have suffered, however, it can help them cover medical expenses and replace income lost from an inability to work. Contact our firm to find out if you qualify for a pancreatic cancer lawsuit.
Loved ones of patients who lost their life because of their injuries caused by the use of Januvia and/or Janumet may be eligible to file wrongful death claims. The relief sought by plaintiffs includes:
- Past and future medical bills
- Home health care
- Past and future lost wages
- Pain and suffering
How Much Does a Pancreatic Cancer Lawsuit Cost?
Consultations at The Carlson Law Firm are free and confidential. Our firm works on a contingency fee basis. This means that if you decide to hire The Carlson Law Firm for your pancreatic cancer lawsuit, you will not be charged any fees unless you first recover.
Why choose The Carlson Law Firm for your Incretin Lawsuit
The Carlson Law Firm has been holding big pharmaceutical manufacturers responsible for injuring innocent victims with their defective drugs for over 40 years. In addition, these companies are some of the largest, wealthiest, and most influential corporate entities in the world, which is why it is important that you have a skilled and knowledgeable team on your side.
If you or someone you love suffered harm by Januvia or Janumet you might have the right to financial compensation for your injuries and losses. Here at The Carlson Law Firm, we will provide a level of representation that has been given recognition with awards and accolades that can be used to your advantage. Moreover, we promise to provide victims with quality representation.
Contact us today for a free evaluation of your case so that we can provide you with the necessary information to help you take the very best course of action. We care, we can help.