Tasigna Lawsuit

What Tasigna Lawsuits Are There?

The company that manufactured the drug product Tasigna, or nilotinib, is facing lawsuits for injuries. Plaintiffs have claimed that the severity of the side effects and cardiac problems related to the drug were not disclosed in the marketing of Tasigna. Patients who have taken this medication may be entitled to compensation for their losses.

Novartis, the manufacturer of Tasigna, was also previously accused of paying kickbacks to specialty pharmacies for promoting Tasigna and other company products. Recently, according to the United States Judicial Panel on Multidistrict Litigation, there currently are thirty-seven active lawsuits regarding the negative side effects of the Tasigna medication in 2023.

Why Did People File Tasigna Lawsuits?

In some cases, there have been fatalities due to ingestion of Tasigna. In other cases, there have been reports of cardiac problems such as irregular heartbeat or chest pain after taking prescribed doses of Tasigna. As a whole, people have filed lawsuits against Novartis for injuries caused by Tasigna such as:

• Heart attack
• Stroke
• Amputation
• Sudden death

The complications cited in the lawsuits are separate and different from any events that may be caused by cancer and are a result of Tasigna use.

What Tasigna Lawsuit Settlements Are There?

 In 2015, Novartis agreed to pay $390 million to several federal and state governmental agencies to settle illegal marketing claims. In 2021, the Middle District of Florida moved Tasigna cases into class-action lawsuits. Today in 2023, there are still active lawsuits against Novartis, but none of them have yet been settled.

What Is Tasigna?

Tasigna (nilotinib) is a medication used to treat an aggressive type of leukemia. It has typically been shown to be effective when a patient’s leukemia is not treatable with other medications such as imatinib or Gleevic, otherwise known as tyrosine-kinase inhibitors. Since the drug’s approval in 2007, Tasigna has treated 28,000 people in the United States with Philadelphia chromosome-positive chronic myelogenous leukemia.

What Is a Tyrosine-Kinase Inhibitor?

Tyrosine-kinase inhibitors are a targeted cancer treatment that manages how much a cell grows or divides in the body. This form of medical therapy can help people with terminal illnesses live longer, or put them entirely into remission. Tyrosine kinases specifically are the enzymes that have the power to help cells divide. With cancer, these cells begin to mutate and create abnormal tyrosine-kinases. 

Is Tasigna Available Over the Counter?

Tasigna is not available over the counter. It requires a doctor’s diagnosis and prescription before a patient can begin taking the pills orally.

Who Manufactures Tasigna?

Taxotere is manufactured by Novartis, a pharmaceutical company based in Switzerland. While they are based in Switzerland, the company has had a large medical presence in the United States. Novartis was founded in 1996 under the merger of two different companies, Sandoz and Ciba-Geigy. In addition to manufacturing Tasigna, Novartis also develops:

• Diagnostic testing programs
• Vaccines
• Animal healthcare
• Medicine (generic, over-the-counter, pharmaceutical)

The company Novartis creates drugs for ailments such as cardiovascular disease, cancer, and brain and spine disorders.

When Was Tasigna Developed?

The Tasigna (Nilotinib) therapy was approved for release by the FDA in 2007. However, it was created by scientists in 2002. During these five years, several clinical trials took place to test the effectiveness of Tasigna’s hematologic response to white blood cells in cancer patients. After the research and government approval was granted, it reached the U.S. market for the treatment of leukemia patients, as well as treatment for patients worldwide. Before the time of the drug’s subsequent lawsuits, the creators at Novartis saw the release of the medicine as a positive step in treating leukemia patients who were not healing due to previous drug resistance.

How Was Tasigna Marketed?

Tasigna has been accused of illegal marketing tactics of Tasigna. It was heavily marketed to healthcare companies and patients for its effectiveness against cancer cells. However, despite its high-reach marketing campaign, the company faces allegations of failing to disclose the severe and sometimes fatal effects of the drug. Patients who took the drug were not adequately warned in the marketing materials of the harm that could occur outside of normal cancer symptoms such as stroke, heart attack, and in some cases sudden death. The company Novartis has been known to have reached high profits for its pharmaceutical sales, and despite knowing about the risks of Tasigna through clinical trials, Novartis still failed to warn the public. Despite the accusations against the company over the years, 2023 market reports have projected there will be continued sales growth in the Tasigna drug market.

How Does Tasigna Work?

Tasigna works by binding to BCR-ABL proteins to inhibit the growth of cancer cells. In leukemia patients, their bone marrow makes too many abnormal white blood cells for the body to keep up with. When patients take Tasigna, their white blood cell count can be stabilized. The enzyme needed for the division of rapidly dividing cancer cells is then fully blocked, helping sick patients live longer and keep their cells at a normal level.

What Does Tasigna Treat?

Tasigna was primarily developed to treat Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML).

What Is Ph+CML?

Philadelphia chromosome-positive chronic myelogenous leukemia, or Ph+CML for short, is an aggressive type of cancer. It occurs when a patient’s white blood cell count becomes too high, which affects the bone marrow. When someone has an abnormal chromosome or a Philadelphia chromosome, it causes the present white blood cells to spread uncontrollably. As time goes by, those white blood cells travel through the bloodstream and start to take over healthy cells, which leads to a person starting to experience signs of illness such as breathlessness and fatigue.

What Phases of Ph+CML in Patients Does Tasigna Treat?

There are three phases of Ph+CML seen in patients:

• Chronic
• Accelerated
• Blastic

What Is Chronic Ph+CML?

In the chronic phase of PH+CML, the white blood cell count is still low. However, the cell count stays consistent and shows that the illness can progress further within the bone marrow and spleen.

What Is Accelerated Ph+CML?

When white blood cells start multiplying, this is the accelerated phase of leukemia. The abnormal Philadelphia cells are increasing in a person’s body, and treatment becomes more difficult during the cell’s multiplication process.

What Is Blastic Ph+CML?

In the blastic phase of Ph+CML, this is when clear damage to the lymph nodes and other organs has occurred. In this phase, treatment becomes increasingly challenging as patients start to become resistant to a drug’s effectiveness. 

What Are the Side Effects of Tasigna?

The most common side effects of taking Tasigna are:

• Nausea and vomiting
• Decreased appetite
• Abdominal pain
• Constipation or diarrhea
• Hair loss
• Rash and itching
• Dry skin
• Fever
• Fatigue
• Headache
• Muscle or joint pain
• Insomnia
• High blood pressure
• Laboratory abnormalities

Severe or sudden side effects should be reported to a medical professional immediately.

What Are the Serious Side Effects of Tasigna?

Some more serious side effects can occur when taking Tasigna for cancer treatment, including pneumonia, myelosuppression, intracranial hemorrhage, and QT prolongation. Patients experiencing any of these symptoms should contact a medical professional.

What Is Pneumonia?

Pneumonia is an upper respiratory infection that occurs when the air sacs fill with fluid. It can be caused by bacteria or other airborne particles present in viruses and fungi. Some cases of pneumonia are less serious and can easily be eradicated with antibiotics, however, more severe cases could be fatal.

What Are the Symptoms of Pneumonia?

The symptoms of pneumonia are shortness of breath, coughing, chest pain, and fever or chills. Most cases of pneumonia require treatment from a doctor, so if you are coughing up mucus or having trouble breathing seek professional care.

What Is Myelosuppression?

Myelosuppression, or bone marrow suppression, is characterized by the bone marrow in the body not making enough blood cells. It commonly occurs in patients with suppressed immune systems from cancer treatment, and it disrupts the bone marrow’s ability to produce healthy red blood cells. People with myelosuppression also have an increased risk of developing another blood disorder such as anemia.

What Are the Symptoms of Myelosuppression?

Symptoms of myelosuppression include headache, irregular heartbeat, pale skin, dizziness, and shortness of breath. Myelosuppression can lead to other disorders and diseases of the blood, so it’s important to seek treatment for the root cause immediately.

What Is Intracranial Hemorrhage?

An intracranial hemorrhage is when there is significant bleeding in the brain. When there is bleeding between the brain tissue and the skull, this can be life-threatening. Brain bleeds are commonly caused by head trauma and traumatic brain injury, but some medications can cause an intracranial hemorrhage too. 

What Are the Symptoms of Intracranial Hemorrhage?

The most frequent symptoms detected with an intracranial hemorrhage are a severe headache, sensitivity to light, blurred vision, slurred speech, loss of consciousness, lack of balance, or in some extreme cases a seizure. Brain bleeds are a medical emergency. 

What Is QT Prolongation?

QT prolongation, otherwise known as Long QT syndrome, is a heart conduction disorder. In Long QT syndrome, patients tend to experience extremely fast heartbeats or even fainting. Common causes are an unhealthy lifestyle or medication side effects. If the root cause of the prolongation is not addressed, the syndrome could be prolonged and eventually cause death.

What Are the Symptoms of QT Prolongation?

Common symptoms of a QT prolongation are fainting spells, seizures, and fast heartbeat. Some patients taking Tasigna have also experienced sudden death.

Does Tasigna Have Cardiac Complications?

Tasigna may increase the risk for cardiac complications, including heart attack, stroke, and amputation due to arterial occlusion. Increased cardiac risk may be a result of developing atherosclerosis due to Tasigna’s effects. In part, due to an increased risk of atherosclerosis which may clog arteries, Tasigna use may result in a higher than normal rate of arterial blockage in arteries in the heart and other areas of the body. Blockage of arterial blood flow around the heart may cause ischemic heart disease and may increase the risk of a heart attack. In the brain, similar blockage can result in cerebrovascular accident (CVA) or stroke.

When arterial blockage occurs in the extremities, it is known as peripheral arterial occlusion which may cut off blood flow and oxygen supply to the arms or legs and may result in tissue death and a need for amputation. Some of the cardiac symptoms reported include:

• Chest pain
• Tingling in the arms or legs
• Head pain

What Black Box Warnings Has the FDA Issued for Tasigna?

The FDA issued a warning about the serious cardiac effects of Tasigna. The FDA has required that all Tasigna prescribing information include “black box” or “boxed statement” warnings regarding the risk of serious cardiac effects.

What Does the Tasigna Black Box Warning State?

Tasigna’s black box states that the use of the medication may cause a change in the heart rhythm known as “QT prolongation,” which may lead to sudden death. Patients who have low magnesium (hypomagnesemia) or low potassium (hypokalemia) levels and those who have preexisting QT prolongation may be at increased risk of sudden death. Use of other medications that prolong the QT interval and certain antacids, antibiotics, or other medications known to be strong CYP3A4 inhibitors should be avoided as they may increase the risk of dangerous side effects.

Has Tasigna Been Recalled?

Tasigna has not been recalled and is still on the market for doctors to prescribe to patients, despite its risks. Novartis failed to warn U.S. physicians and consumers about the risk of Tasigna, even though doctors in Canada had been warned. The company did not issue safety alerts in the U.S. about the increased risk until they were forced to address the problem by the U.S. Food and Drug Administration (FDA). While Novartis paid a settlement in 2015 for illegal marketing, there are still patients filing lawsuits against Novartis for the negative side effects of Tasigna today.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.