Update: Novo Nordisk Sues Mylan Over Generic Victoza
August 23, 2019 – Novo Nordisk has filed a patent protection lawsuit against Mylan Pharmaceuticals over its attempt to buy and market a generic version of the Victoza Pen, according to Nasdaq. Novo owns the patent on Victoza, which protects it from generic competition so the company can “recoup their investments by charging monopoly prices,” according to StatNews. Victoza’s first patent expires in July 2021, and its last in March 2033, so Mylan will have to wait to get its hands on the widely-prescribed diabetes pen.
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 Treatment & Drugs
Depending on the type and stage of the disease, Victoza-induced pancreatitis can be treated in a number of different ways, and with a variety of different drugs. People suffering from pancreatitis are usually first admitted to a hospital, where the pancreas can be examined and treated by a medical team. Methods of treatment may include fasting, pain medications, IV fluids, and surgical intervention.
Individuals suffering from Victoza-induced pancreatitis should be taken to a hospital where the inflammation of the pancreas can be brought under control and the patient can be made as comfortable as possible. Subsequent methods of treatment may include:
- Fasting – Patients are typically advised to stop eating for a period to allow their pancreas time to recover. Once the inflammation subsides, the patient may resume drinking clear liquids and eating bland foods.
- Pain medications – Commonly prescribed to patients experiencing serious pain caused by pancreatitis.
- IV fluids – As the body needs copious amounts of fluid to repair the pancreas, the person may become dehydrated. To avoid this, patients may receive additional fluids intravenously.
Once inflammation in the pancreas has been brought under control, treatment can shift to the underlying cause of the disease. The doctor is likely to recommend discontinuing Victoza in favor of another diabetes medication with fewer potential complications. Other methods of treatment include:
- Bile duct blockage removal – In people whose pancreatitis is caused by blocked bile ducts, an endoscopic retrograde cholangiopancreatography (ERCP) may be used. This device can help in diagnosing problems with the pancreas and making repairs.
- Gallbladder removal surgery (cholecystectomy) – In cases where the disease is caused by gallstones, a cholecystectomy may be performed to extract the gallbladder.
- Pancreas surgery – Performed to drain fluid or remove necrotized pancreas tissue from the patient.
- Enzyme supplements – Prescribed to help the body digest nutrients from food. Supplements typically come in pill form and are taken at meal time.
- Dietary changes – May be beneficial in accommodating the unique nutritional requirements needed for patients suffering from pancreatitis.
Pancreatitis Tests & Diagnosis
The diagnosis of Victoza-induced pancreatitis can be difficult because routine blood studies may not necessarily show elevations in digestive enzymes. The most important clue to a proper diagnosis of the disease is a comprehensive medical history. This article discusses the various tests doctors use to diagnose Victoza pancreatitis.
There are a number of diagnostic tests that can be implemented to diagnose Victoza-induced pancreatitis. The process typically begins with a plain film of the abdomen. The finding of pancreatic calcification is indicative of pancreatitis, but often times it is not found. Tests used to confirm the diagnosis may include:
- Ultrasonography – Device that sends high-frequency sound waves into the patient’s abdomen. The echoes that the sound waves produce as they bounce off internal organs creates a picture called a sonogram.
- Computed Tomography (CT) Scan – Involves the use of a large x-ray machine which the patient passes through to produce a detailed picture of the pancreas.
- Endoscopic Retrograde Cholangiopancreatography (ERCP) – Takes x-rays of the common bile duct and the pancreatic ducts. During an ERCP procedure, an endoscope is passed down the throat, through the stomach, and into the small intestine. Dye is then injected into the ducts and x-rays are taken.
- Endoscopic Ultrasound (EUS) – Test that combines ultrasound (sound waves) with an endoscope. The endoscope is inserted into the stomach and the ultrasound machine directs sound waves at the pancreas.
- Magnetic Resonance Imaging (MRI) – Involves moving a large x-ray machine around the patient’s body while simultaneously taking pictures. The computer then combines the x-rays to produce detailed images.
Additional tests to diagnose Victoza-induced pancreatitis may include a glucose tolerance test to measure damage to the cells in the pancreas, and a biopsy where tissue is extracted from the pancreas.
For individuals suffering from Victoza-induced pancreatitis, complications can be painful and long-lasting. In many cases, pancreatitis can lead to full-blown pancreatic cancer if the condition is not treated in a timely manner by a team of medical professionals. Some of the most commonly reported Victoza pancreatitis complications include nutritional deficiencies, buildup of fluid in the abdomen, and the development of type 2 diabetes.
Victoza pancreatitis complications may include:
- Nutritional Deficiencies – When the pancreas is unable to properly secrete enzymes, the body cannot absorb nutrients from foodstuffs. If this is the case, enzyme supplements may be prescribed in order to prevent malnutrition.
- Fluid Accumulation in the Abdomen – Victoza-induced pancreatitis can cause fluid to build up in the abdomen. If this occurs over a prolonged period of time, a mass called a pseudocyst can form which may be so large that it obstructs the ducts and causes extreme pain and vomiting.
- Increased Risk for Pancreatic Cancer – Individuals diagnosed with pancreatitis are up to three times more likely than the general population to go on to develop full-blown pancreatic cancer.
- Development of Type 2 Diabetes – If left untreated, pancreatitis may cause the pancreas to lose its ability to produce insulin. This results in the patient developing type 2 diabetes, the very disease Victoza is used to treat. In such cases, patients are forced to take insulin in order to regulate their blood glucose levels.
Other potential complications associated with Victoza-induced pancreatitis may include kidney failure, hypoxia, infections, shock, organ damage, and death.
In clinical trials, some patients taking the type 2 diabetes drug Victoza (generic: liraglutide) developed pancreatitis. Prior to the drug’s approval by the U.S. Food & Drug Administration (FDA) in 2010, there was already concern that Victoza causes pancreatitis because previous studies showed that Byetta, another diabetes drug in the same class as Victoza, caused the formation of pancreatitis in laboratory rats. If you have taken Victoza and subsequently been diagnosed with pancreatitis, you may be at risk of developing full-blown pancreatic cancer.
It has recently been found that incretin mimetic diabetes drugs like Victoza have the potential to cause pancreatitis. In pre-approval clinical trials, seven Victoza users developed pancreatitis. Five cases were described as ‘acute’ pancreatitis, characterized by a sudden and severe onset of the disease, and the other two were chronic and developed slowly over a long period of time. One of the seven patients with pancreatitis eventually developed pancreal necrosis and subsequently died, although it is unclear whether Victoza played a role in the death.
Victoza warning labels describe the symptoms of pancreatitis as “persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting.” The warning also states that Victoza may cause:
- tissue damage
- cellular necrosis
If the pancreas hemorrhages, fluids released can affect the functioning of nearby organs. In severe cases, acute pancreatitis has been known to be fatal. Anyone experiencing characteristic symptoms should contact their doctor right away.
In March 2013, the FDA issued a Drug Safety Communication informing the public and medical communities that it is in the process of evaluating unpublished studies which linked Victoza with pancreatitis and abnormal cellular changes known as “pancreatic duct metaplasia.” The administration is requesting that the research teams provide it with their methodologies and tissue samples used in the studies.
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.”
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.
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. You may be entitled to compensation by filing a class action suit and our lawyers can help.