Victoza (liraglutide) is a brand of the Danish manufacturer Novo Nordisk. This drug was approved by the US Food and Drug Administration (FDA) in 2010. It is a once a day injectable drug that is designed to mimic the glucagon-like peptide 1 receptor antagonist (GLP-1). This is the hormone that delays emptying of the stomach and suppresses postprandial glucagon release while increasing insulin sensitivity.
Novo Nordisk has marketed this drug in the United States and European Union under their brand-name Saxenda though in a different dose. Patients self-inject the drug subcutaneously. Apart from Victoza, there have been numerous safety concerns against incretin mimetics including; Byetta, Janumet, and Januvia.
What is Type 2 Diabetes?
Diabetes is a chronic disease that is characterized by high blood sugar levels. High blood sugar can sometimes be termed as normal, but if chronically high it can cause serious complications. Prolonged diabetes and poor blood sugar management can cause nerve damage, vision loss, heart disease, and stroke.
In a healthy person, insulin, a hormone produced in the pancreas is released when there are abnormally high levels of blood sugar. It helps regulate blood sugar to normal levels. In someone with type 2 diabetes, the pancreas may have slowed down the production of insulin or the body may not be as sensitive to insulin. Lifestyle changes may reverse type 2 diabetes but drugs are also quite helpful in managing the disease.
How Does Victoza Work?
Liraglutide belongs to a category of diabetes drugs called incretin mimetics. This drug mimics the hormone called glucagon-like peptide-1 (GLP-1) that plays various roles in the body. This hormone acts on the gut, pancreas, and liver.
Victoza (liraglutide) is designed to improve the regulation of blood glucose levels and reduce hyperglycemia after meals. It achieves this by increasing insulin secretion when necessary. The drug also curbs the patient’s appetite to prevent weight gain while lowering blood triglyceride levels. The medication only stimulates insulin secretion when the patient has abnormally high glucose levels. The drug can also inhibit programmed cell death (apoptosis).
How is it Administered?
Victoza (Liraglutide) is an injectable drug. The patient injects the medication into the upper-arm or thigh. It comes with an injecting device that is preloaded with precise doses of the drug. Dosage may vary from patient-to-patient but the patient typically uses the injection around the same time every day.
Victoza Allergic Reactions
An allergic reaction occurs when your immune system over-reacts to a substance considered rather harmless. Victoza is one of the drugs known to cause serious allergic reactions.
In five clinical trials of Victoza that lasted 26 weeks, 80% of the patients experienced a serious allergic reaction. This included swelling, redness, and hives as compared to just 40% of people treated with similar drugs. It is estimated that 2% of people treated with Victoza experienced injection site reactions. This included rashes at the site of injection and during the trials, 0.02% of the patients stopped taking Victoza due to serious allergic reactions.
When a patient experiences an immune response to a substance their body produces antibodies that are tailored to identify and attack the substance. During Victoza clinical trials 8.6 % of the participants tested positive for Victoza antibodies. It was noted that in 6.9% of the patients the antibodies also attacked the GLP-1 hormone that Victoza mimics.
Who Should Avoid Taking Victoza?
Anyone can suffer a hypersensitivity or allergic reaction to new medication including Victoza (Liraglutide). Victoza has been contraindicated for patients with a history of Type 2 Multiple Endocrine Neoplasia Syndrome and Medullary Thyroid Carcinoma. Victoza does not also treat Type I diabetes mellitus.
Allergic Reactions Linked to Victoza:
- Upper respiratory tract infections
- Gastrointestinal events
- Injection site reactions
Symptoms of a Victoza Allergic Reaction
- Swelling of the face, lips, throat or tongue
- Problems swallowing
- Fainting and dizziness
- Rapid heartbeat
- Breathing problems
- Severe rash
Victoza and Kidney Failure
Though Victoza has shown to be effective in the regulation of blood sugar levels, it sometimes causes some serious side effects. It has been discovered that even at the recommended dosage Victoza may significantly increase the risk of a patient developing kidney/renal failure.
Kidney or renal failure is a serious medical condition whereby kidney function is impaired and they are unable to filter out excess fluids, waste material, toxins and salt from the bloodstream. The severity of the condition directly correlates to the extent of the damage and duration that it has pre-existed. Kidney failure is therefore categorized as either Acute Kidney Injury (AKI) or Chronic Kidney Disease (CKD).
Acute Kidney Injury is a condition where your kidneys suddenly stop functioning in two days or less. This causes a build-up of waste products and toxins. Chronic kidney disease is a gradual loss of kidney function from Stage 1 (mild damage) to Stage 5 (complete kidney failure).
Victoza has been known to cause nausea, vomiting, and diarrhea which can cause acute dehydration resulting in kidney failure. This can happen in patients who have never experienced any problems with their kidneys.
After Victoza approval by the FDA in 2010, there has been a significant number of reports of patients using the drug who have suffered kidney failure. This prompted the FDA to demand that Novo Nordisk update their Victoza label to include a warning on Acute Kidney Injury (AKI) and worsening of Chronic Kidney Disease (CKD).
Signs and Symptoms of Kidney Disease
- Pain on one side of the back, above the waist or below the ribcage.
- Changes in consciousness (dizziness, fainting to going comatose).
- Thirst accompanied by a dry mouth.
- Swelling of the legs or feet
- Little to no urination
- Loss of appetite
- Rapid heart rate
Having been approved by the FDA in 2010, Victoza does not have an adequate safety history. Though it has been linked to Acute Kidney Disease and Chronic Kidney Failure it may take years for the symptoms to develop.
Victoza and Thyroid Cancer
Patients using Victoza for the treatment of Type-2 Diabetes have an increased risk of developing thyroid cancer and more specifically Medullary and Papillary thyroid cancers.
The thyroid is a butterfly-shaped gland located at the base of the neck. Thyroid cancer occurs in the cells of the thyroid and as they metastasize the cancerous cells consume the remaining healthy ones. If left untreated it eventually leads to the death of the thyroid. The thyroid produces hormones responsible for regulating your body temperature, heart rate, blood pressure, and weight. Without the thyroid, a patient may experience life-threatening complications.
Before Victoza was approved by the FDA, Novo Nordisk conducted pre-approval safety studies on diabetic rodents. It was found that Victoza caused malignant tumors in the thyroid of the rodents. The risk was higher at high doses, but there was also an increased risk with normal usage. This was a clear indicator that Victoza could potentially cause thyroid cancer in humans. The FDA required that Novo Nordisk warns medical professionals about the risk of thyroid cancer with the use of Victoza and to keep track of this development over the next 15 years.
According to studies, there is a higher risk of thyroid cancer in patients using Victoza compared to others using another diabetes type 2 medications. It has been noted that thyroid C-cell hyperplasia is 2.4 times more common in Victoza patients. Papillary Thyroid cancer is 3 times more common in patients using the drug.
Symptoms of Thyroid Cancer
- A visible lump on the neck
- Hoarseness or change in voice
- Difficulty swallowing
- Pain in the throat or neck
- Swollen lymph nodes
FDA Safety Alert
According to the FDA use of liraglutide causes dose and treatment duration dependent thyroid C-cell tumors in rodents. When Victoza was approved in 2010 the FDA noted that clinical data suggested that medullary thyroid cancer was linked to the use of Victoza.
Victoza Thyroid Cancer Lawsuit
Based on a number of animal studies the FDA announced that Victoza caused cancerous tumors in the thyroid glands of rodents. There was an adverse events report submitted to the FDA in 2012. According to the report, there were more than 17 thyroid cancer cases associated with the use of Victoza were highlighted by the Institute for Safe Medication Practices.
Victoza and Pancreatic Cancer
The pancreas is a digestive gland that also produces the hormone insulin. In most cases, pancreatitis occurs when pancreatic enzymes are activated within the pancreas and not the small intestines. Victoza (liraglutide) may catalyze the development of this condition. In normal circumstances, digestive enzymes secreted by the pancreas remain inactive until they reach the small intestines. But in this case, inflammation caused by pancreatitis causes the enzymes to attack and damage the tissue that produces them. Pancreatitis can either be acute or necrotizing.
Symptoms of Pancreatitis
The pancreas is located in the middle of the abdomen. The first symptom of pancreatitis is usually abdominal pain. The pain gets worse after a patient eats or drinks and especially if they consume high-fat foods.
- Abdominal pain that gets worse after eating and radiates to your back.
- Abdominal tenderness
- Rapid heartbeat and breathing
- General malaise (sweating, vomiting, nausea, fever)
- Clay-colored, oily and smelly stool (steatorrhea)
In March 2013 the FDA issued a Drug Safety Communication notifying the public that there was a study that linked Victoza and other Liraglutide diabetes medications to increased risk of pancreatitis and pre-cancerous cellular changes commonly referred to as pancreatic duct metaplasia. The risk was associated with the incretin mimetics group of drugs which includes; Januvia, Byetta, Bydureon, and Victoza.
Victoza Pancreatic Cancer Lawsuit
The entire category of incretin mimetics drugs has been associated with a potential risk of pancreatitis and pancreatic cancer. There has been a continuous evaluation of Victoza lawsuits for individuals who have developed pancreatic cancer with use of the drug.
According to reported cases, these problems start with inflammation of the pancreas (pancreatitis) which later develops into cancer. During the initial 17 months that Victoza was on the market over 200 new cases of acute pancreatitis were reported to the FDA. This was a significant risk factor for users of the drug developing pancreatic cancer from chronic inflammation and increased cell turn over.
In 2013, the FDA issued an announcement that the agency was conducting an investigation on the probable risk of pancreatic cancer with the use of Victoza and other Liraglutide drugs. This was after a study of pancreatic tissue of patients using the drug indicated that there was inflammation of the pancreas and cancerous cell changes.
Novo Nordisk is accused of withholding information on the potential of the drug causing pancreatitis and pancreatic cancer. Therefore, preventing medical professionals and patients from making informed decisions on whether the benefits justified the dangers informed.
Consequently, the FDA placed a black box warning (the most stringent) on Victoza’s labels. However, the FDA made a declaration that there was no documented evidence that linked Victoza to human tumors. The FDA also advised patients not to consider Victoza as their first option until there was more clarity on the drug. They regulator also prohibited patients with thyroid cancer or a history of thyroid cancer from taking the drug.
Even before the FDA approved Victoza in 2010 there were numerous agencies and researchers that were raising questions about problems associated with Victoza. However, the FDA went ahead and approved the drug.
In April 2012, Public Citizen a consumer advocacy group filed a petition for the recall of Victoza. They wanted the FDA to pull out Victoza from the market. However, to date, no recall has been made either by the FDA or voluntarily by the drug manufacturer.
Did you know that medical errors are the third leading cause of death in the US after heart disease and cancer? Lax oversight and inadequate clinical trials can be attributed to increased injuries from medical products.
The U.S. Food and Drug Administration (FDA) approves hundreds of medical drugs and devices each year. They are tasked with testing the safety and effectiveness of these medical products. However, a focus on profits has resulted in lax testing, questionable trial results and needless to say innumerable customer injuries. Cases involving defective medical devices and injuries can be complex since they not only have an element of state law but federal safety as well.
When a medical drug or device does work as intended the side –effects and complications can be devastating. If you or a loved one are in such a situation you need the services of an attorney with mass tort experience in defective medical devices and drugs. They will help you build a strong case to hold prescription drug companies and medical device manufacturers accountable for manufacturing defects, inadequate testing, warning, and faulty design. This will ensure that you’re compensated for all the pain and suffering caused.
Dangerous Pharmaceuticals Mass Tort Cases
A mass tort is a civil action taken by several plaintiffs against one or several defendants. The difference between mass tort and class action suits is that they are filed individually. They should also not be confused with personal injury suits. Mass tort cases encompass multiple claims on a single product. The basic facts of these claims are similar and the individual claims are addressed together financially.
Some Basic Facts About Medical Mass Tort Cases
- These cases can either be filed at the state or federal level.
- They usually include a large number of plaintiffs and defendants
- Depending on the state there are different laws dictating the level of damages and which ones are valid.
- Different states have different statutes of limitations and levels of liability.
- Mass tort cases sometimes reveal third party issues.
Mass Tort Claims for Harmful Medical Devices and Drugs Will Allow You and Your Loved One Compensation for The Following Damages:
- Lost income and future earnings
- Medical expenses
- Funeral expenses
- Pain and suffering
- Emotional damages
There are diverse factors that determine how much a mass tort claim is worth. All cases are different and though an experienced attorney can give you an educated assessment of how much your claim may be worth, they cannot guarantee you a specific compensation amount.
What Are Some of the Factors Considered When Determining the Worth of a Mass Tort Claim?
- Kind of injury
- Type of medical treatment
- Preexisting medical conditions
- Liability of all parties involved
- The ability of the injured person to return to work
- Location of the injury
- Need for future medical treatment and any other kind of support
Laws vary widely from state to state and some states have enforced laws to protect their residents better. Your state plays a critical role in the valuation of your claim. There are states that allow unlimited recovery of non-economic damages such as emotional suffering; other states have limitations on this kind of recovery. State laws on negligence, comparative fault and other kinds of liability also greatly affect the value of these claims.
How Long Do Mass Tort Cases Take?
There is no standard time frame. In some cases, settlement is reached even without filing a suit. However, often these cases aren’t settled until it’s very close to trial, which can extend to a year or more after the initial filing.
If you win and a judgment is entered the defendant may settle at that time. He may also appeal the judgment and in this instance, the ultimate recovery could take months or even years. If you lose at trial you definitely have the right to appeal.
Product Liability Claims for Pharmaceutical Drugs
If you or a loved one has been injured by a medical drug, you may institute a defective product liability claim. A pharmaceutical drug liability claim is similar to all other defective product claims, however, there are quite a number of distinctive features.
What are The Different Categories of Pharmaceutical Drug Liability Claims?
They can be classified into three major categories:
- Defectively manufactured drugs
- Pharmaceutical drugs with dangerous side effects
- Inappropriately marketed pharmaceutical drugs
Defectively Manufactured Pharmaceutical Drugs
This category of product liability claims comprises of injuries caused by medical drugs that are inappropriately manufactured or that have become contaminated in the manufacturing process. This comprises of mistakes made at any point between the factory and where you receive the drugs. This can be an error made in the manufacturing or bottling drugs, a labeling or shipping error before the final consumer receives the drug.
Pharmaceutical Drugs with Dangerous Side Effects
This group of product liability claims involves medical drugs that have been properly manufactured but cause serious side effects. This may be as a result of inadequate testing and clinical trials. This category of cases sometimes involves drugs that have been on the market for long and maybe even years before a discovery is made that they cause certain side effects or increase the risk of consumers suffering from a certain condition such as high blood pressure. In quite a number of cases, the manufacturer is found to have known that the drug posed serious health risks but intentionally concealed this information. If this is proved, victims are likely to be compensated handsomely in the form of punitive damages.
Improperly Marketed Pharmaceutical Drugs
Proper warnings, instructions, recommendations and any other information critical to a consumer regarding the use of a drug is the marketing aspect of the drug. These claims involve injuries that result from a failure to furnish consumers with accurate and adequate warnings regarding serious side effects or contraindications. This can also be a failure to give adequate instructions on the safe and proper use of a drug. The failure of providing this critical information may fall on; the manufacturer, pharmacist, doctor, sales representative or any other person in the supply chain.
Every defective product lawsuit is unique and may comprise of several claims. A defectively manufactured drug lawsuit may be combined with a dangerous side effects claim. Each pharmaceutical product liability claim may involve one or more defendants.
Finding Help for a Defective Drug or Device Near Me
Victoza and other incretin mimetics class of drugs are subject to numerous lawsuits because of their dangerous side effects. Lawsuits against Novo Nordisk commonly site inadequate warning as the cause of illness.