Tasigna (nilotinib) — a drug approved by the U.S. Federal Drug Administration to treat patients with Philadelphia chromosome-positive chronic myelogenous leukemia (CML) — has allegedly caused severe side effects in some patients, such as blocked arteries, stroke, and even death.
Lawsuits have already been filed against the drug’s manufacturer Novartis, alleging the company failed to warn patients of the potential side effects. If you or a loved one has experienced any heart or circulation problems while taking Tasigna, you may also be able to file a lawsuit and recover compensation for the damage. Contact Ben Crump Law today, to learn more about how his firm may be able to help.
What is Chronic Myelogenous Leukemia?
CML is a form of leukemia that develops in blood-forming cells of the bone marrow, according to the American Cancer Society.
leukemia cells divide and make new cells faster than normal and live longer than they should. As a result, these cells build up in the bone marrow, crowding out healthy cells. Eventually, the leukemia cells spill into the bloodstream and spread to other parts of the body.
Chronic leukemia can take many years before it causes problems and people can live for several years following a diagnosis, according to the ACS. That being said, chronic leukemia is often more difficult to cure than acute leukemia.
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How Does Tasigna Treat CML?
Tasigna was approved by the FDA in 2007 to treat patients with CML. Tasigna is part of a class of drugs known as tyrosine kinase inhibitors (TKIs), so named because they target tyrosine kinase proteins — a protein that stimulates the growth of cancer cells. By blocking the protein, Tasigna slows the spread of leukemia cells and helps patients with CML live longer.
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What are Tasigna’s Alleged Cardiovascular Side Effects?
To date, there have been over 13,000 Tasigna-related adverse events — including 2,438 deaths — reported to the FDA. Among the adverse events reported to the FDA, there are several serious cardiovascular side effects, such as Long QT syndrome, myocardial ischemia, and atherosclerosis.
Long QT Syndrome
Long QT syndrome is a condition that affects heart rhythm, resulting in fast, irregular heart beats that can result in sudden fainting, a seizure, and even death. In recognition of long QTs seriousness, the FDA issued a black box warning — the highest warning it can issue — on Tasinga to warn patients of the potential side effect.
Myocardial ischemia is caused by a blockage in the coronary arteries that reduces blood flow to the heart. When that happens, an irregular heartbeat may develop, and if the blockage is severe enough, it may cause a heart attack.
In an FDA post-market review, 5.8 percent of patients taking Tasigna allegedly suffered heart disease-related events caused by a blockage that prevented the heart from getting enough blood.
Atherosclerosis is a condition that causes plaques of fatty deposits to build up on an artery’s interior wall and prevent blood from flowing freely. If the blockage is left untreated, atherosclerosis can cause coronary artery disease, peripheral arterial disease, blood clots, heart attacks, or strokes. Atherosclerosis is so serious, that it’s currently the leading cause of death in the developed world.
Canada has recognized this serious side effect since 2013, when a warning label alerting patients about the Tasigna’s connection to atherosclerosis was added to its packaging. The label was changed after health officials in Canada warned that 277 cases of atherosclerosis were allegedly reported worldwide.
Other serious potential complications with Tasigna recognized by the FDA include:
- Low blood cell counts
- Decreased blood flow to the heart, lungs, or brain
- Tumor Lysis Syndrome
What Do Tasigna Lawsuits Against Novartis Allege?
Even though the serious cardiovascular side effects have been well known in Canada and included on the warning label there for several years, patients in the U.S. were not as fortunate.
Subsequently, the family of a California man who died of atherosclerosis related symptoms decided to file a lawsuit against Novartis in March 2016, alleging that the company’s U.S. labeling for Tasigna failed to warn patients about possible side effects.
The man was prescribed Tasigna in 2012, and by September of the following year, he allegedly showed signs of atherosclerosis. The condition caused him to develop peripheral artery disease, resulting in 90 to 100 percent artery blockages in his legs. Sadly, he died from complications associated with atherosclerosis in March 2014.
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Ben Crump Law Wants to You Help File a Tasigna Lawsuit
There are risks associated with every drug, but patients need to be informed of these risks to make responsible decisions about their health. When drug manufacturers fail to warn of potential side effects, they jeopardize the health of patients who take their drugs to get better. This is a serious breach of trust.
Novartis allegedly sold its drug Tasigna in the U.S. with an incomplete warning label, even though its label in Canada mentioned certain cardiovascular side effects for years. As a result, some patients in the U.S. are said to have suffered heart or circulation problems, including but not limited to complications like blocked arteries, heart attacks, or strokes without any warning.
To learn more about how Ben Crump Law may be able to help you file a Tasigna lawsuit, contact him today. He and his team may be able to help you recover compensation for medical bills, lost wages, pain and suffering, and more.