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Did You Develop Hardened Arteries after Treatment with CML Drug Tasigna?
If you were treated with Tasigna for CML and developed a dangerous condition known as atherosclerosis or hardened arteries, you may be eligible to seek significant financial compensation for your injuries.
How Tasigna Works
Chronic myeloid leukemia is a type of cancer that forms in the marrow of your bones. It causes an overproduction of white blood cells which can build up in the marrow before spilling into the bloodstream and travel throughout circulatory system to settle in other parts of the body. Tasigna (nilotinib) is approved for use as a treatment for CML, specifically Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML).
Tasigna works by blocking the proteins needed to activate and grow cancer cells, and while it can stop cancer cells from growing and spreading, it does not cause harm to non-cancerous cells. However, the drug has been associated with serious and life-threatening conditions.
Patients who are treated with Tasigna may develop a dangerous and rapidly progressing plaque buildup in their arteries. This condition, called atherosclerosis, can result in tissue death and gangrene, heart attack and stroke, amputations, and wrongful death.
Atherosclerosis causes your arteries to become hard, stiff, and thick with a plaque buildup that decreases blood flow. This hardening of the arteries can cause the development of several serious conditions like blocked blood flow to the brain and may result in stroke; restricted blood flow to the heart; or blocked blood flow to the extremities.
If you have Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) and were treated with Tasigna, and then developed arteriosclerosis or hardened arteries, you may be entitled to seek significant compensation for your injuries.
What is Atherosclerosis?
Atherosclerosis causes your arteries to become stiff with plaque. Plaque is basically fatty deposits comprised of a clotting material called fibrin, plus calcium, cholesterol, and cellular waste. As this fatty buildup continues to progress, the passageway for blood travel become narrower. Pieces of the plaque can also break off into the bloodstream where they can become stuck and grow into clots that block the flow of blood through the artery.
If the vessel that carries blood to the heart is restricted, it is called coronary artery disease. When blood flow is restricted in the vessels that carry blood to the brain, it is called carotid artery disease, and when blood flow from the extremities is restricted it is called peripheral artery occlusion disease or PAOD. When blood flow is blocked from the heart or brain, you can suffer a heart attack or stroke, and restricted blood flow to the legs can result in tissue death and gangrene. The National Institutes of Health report that atherosclerosis is the leading cause of death in this country and other developed countries.
Peripheral Artery Disease
The symptoms of this disease include experiencing temperature differences in the extremities such as one leg that is cooler or warmer than the other, or that is a different color than the other. You may also notice that wounds on your feet do not heal, or experience gangrene. You may suffer leg cramps when you walk or exercise, and if you are a man with diabetes, you may experience erectile dysfunction.
Carotid Artery Disease
Symptoms of this disease are few. Your doctor may hear a whooshing sound when listening to the carotid artery with a stethoscope and send you for further testing. You may also suffer a stroke or mini-stroke if blood flow is restricted in the carotid arteries.
Coronary Artery Disease
The symptoms of coronary artery disease may include tightness, pain, discomfort, or pressure in your chest, or in your shoulders, neck, jaw, back or arms. You may feel short of breath, especially when walking upstairs, or you may experience heart failure, heart attack, or arrhythmia.
Patients who suffered these serious adverse events and the families of patients who died because of rapid hardening of the arteries are filing lawsuits against Tasigna manufacturer Novartis. These lawsuits allege the drug maker knew or should have known about the increased risk of atherosclerosis but did not warn doctors or their patients about this risk. In fact, the family of a patient who died from atherosclerosis-related issues accused the Novartis of knowing for years that the drug caused the severe, rapid, and irreversible development of hardened arteries in some patients.
When Did Novartis Know of the Dangers
One of the biggest issues is when Novartis first had knowledge that use of Tasigna could result in atherosclerosis and when they first warned about this potentially life-threatening side effect.
In 2007, the FDA approved Tasigna for use in the United States. That same year, the government watchdog agency began receiving adverse event reports. Within four years, a clinical study was published in the American Journal of Hematology that associated use of Tasigna with the development of peripheral artery occlusion disease.
This led scientists to investigate the drug and potential health complications further. In 2013, the journal Leukemia published a study in which 159 patients were studied. Researchers had found that of the patients studied, 26 percent on first-line Tasigna and 35.7 patients on second-line Tasigna developed PAOD while only 6.3 percent of patients on alternative but similar medications developed PAOD.
The journal Blood also published a study that year in which scientists observed 34 patients for two years. They found that over 26 percent developed PAOD and more than 17 percent of those patients required extended hospitalization or surgical treatment.
Unfortunately, by that time, the FDA had received nearly 4,400 adverse event reports, yet the manufacturer did not recall the drug or issue a warning to U.S. patients and doctors.
However, the drug maker did warn physicians and patients in Canada of the association between Tasigna and rapidly progressing atherosclerosis. This warning allowed the medical community in Canada and their patients to make informed decisions about their health and whether the benefits of the drug outweighed the risk of rapidly progressing atherosclerosis.
In fact, in Canada, Novartis warned about the risks of Tasigna atherosclerosis in physician’s reference documents, the Health Canada website, consumer information leaflets, and the Novartis Canada website. But the drug maker failed to issue these same types of warnings in America, even though adverse event reports were continuing to be filed. In fact, by the close of 2017, nearly 13,000 adverse event reports had been filed, including nearly 9,000 reports of serious injury and more than 2,300 Tasigna related deaths.
It’s Time to Seek Justice, and We Can Help
Patients who developed atherosclerosis after receiving treatment with Tasigna are seeking justice through the legal system. Lawsuits continue to be filed on behalf of patients who allege they were not adequately warned about the dangers of Tasigna atherosclerosis and its severe and potentially life-threatening side effects. These patients say that unlike Canadian patients, they were denied the chance to make informed decisions about their treatment and care, and they want to know why.
These patients and their families are questioning why a drug maker would warn the medical community in one country of the serious side effects associated with Tasigna but not tell the U.S. medical community. They want to know why the drug maker marketed Tasigna as a safer alternative to other therapies that do not cause rapidly progressing atherosclerosis. Patients say the drug caused them to suffer injuries like the development of coronary artery disease, carotid artery disease, or peripheral artery occlusion disease and amputations, but they were never warned that they might develop these conditions after receiving Tasigna treatment.
Did you know that pharmaceutical companies have a high duty to ensure their products are safe for use? And if a drug maker knows of a danger, side effect or complication of a drug, they are must alert the FDA, the medical community, and their patients. When they fail that duty, they may be held liable by law for resulting injuries.
If you were treated with Tasigna and developed complications from rapidly progressing atherosclerosis, you may be entitled to hold the manufacturer liable for your injuries and losses and you may be eligible for significant financial compensation. In fact, you may be entitled to damages for:
- Loss of companionship in wrongful death cases
- Medical costs and expenses related to your medical care;
- The pain and emotional distress you suffered;
- Court costs and fees; and,
- Any other damages the court deems appropriate.
If you or your loved one suffered atherosclerosis or a resulting complication after being treated with Tasigna, contact us today. We have been fighting for the rights of patients for decades, and we stand ready to fight for you now. Contact us today to learn more about patient rights and whether you can seek justice for your injuries.