Tasigna (nilotinib), is a drug that treats chronic myeloid leukaemia (CML). The drug may be linked to dangerous complications, like blocked arteries, stroke, and even death.

Our attorneys are investigating claims that Tasigna’s manufacturer, Novartis, knew about these side effects but failed to warn the public about them.

How Does Tasigna Work?

Tasigna was approved by the FDA in 2007 to treat Philadelphia chromosome-positive chronic myeloid leukaemia (CML). CML affects the myleoid stem cells, which eventually develop into red blood cells, granulocytes, monocytes, or platelets.

Tasigna is part of a class of drugs known as tyrosine kinase inhibitors (TKIs). Other TKI drugs include Gleevec (imatinib), also made by Novartis, and Sprycel (dasatinib), made by Bristol-Myers Squibb.

These drugs help treat leukemia by blocking the protein tyrosine kinases—a protein that stimulates the growth of cancer cells. In blocking this protein, TKI drugs like Tasigna help stop leukemia from spreading.

Tasigna is prescribed as a twice-daily drug, and is taken orally in capsule form.

What Are Some Common Tasigna Side Effects?

Novartis warns of the following side effects common to Tasigna:

  • Nausea
  • Vomiting
  • Rash
  • Headache
  • Itching
  • Diarrhea
  • Constipation
  • Cough
  • Muscle and joint pain
  • Runny or stuffy nose, sneezing, sore throat
  • Fever

Cardiovascular Complications Allegedly Linked to Tasigna

More than 15,500 Tasigna-related adverse events and 2,786 deaths have allegedly been reported to the FDA to date. Nearly 500 of these reports cited heart attacks, and 273 patients complained of strokes after taking Tasigna.

Other serious cardiovascular side effects cited include QT prolongation, myocardial ischemia, and atherosclerosis.

QT Prolongation (Long QT syndrome)

The FDA warns, “The potential for QT prolongation and sudden death associated with nilotinib, although rare, necessitates vigilant monitoring.”

The FDA issued a black box warning—the highest warning they can issue—for Tasigna’s link to QT interval prolongation and sudden death.

QT interval prolongation is a condition that affects heart rhythm, resulting in fast, irregular heartbeats. If the heart doesn’t return to its regular heartbeat, it can result in fainting, seizures, and sudden death.

On the product label, the FDA warns, “The potential for QT prolongation and sudden death associated with nilotinib, although rare, necessitates vigilant monitoring.”

The FDA recommends physicians conduct electrocardiograms to monitor the QT interval before treatment, seven days after initiating treatment, and periodically thereafter. Tasigna is not recommended for patients with low potassium or magnesium blood levels who may be at greater risk of developing long QT syndrome.

Myocardial Ischemia   

More than 100 reports of Tasigna-related myocardial ischemia diagnoses have been reported to the FDA’s adverse event reporting database.

Myocardial ischemia is a condition that is usually caused by a blockage of the coronary arteries. It results in reduced blood flow to the heart, decreasing the amount of oxygen to the heart.

In an FDA post-market review, 5.8% of patients taking Tasigna allegedly suffered ischemic heart disease-related events.

Atherosclerosis

Canadian health officials warned that 277 cases of Tasigna-related atherosclerosis were allegedly reported worldwide.

Atherosclerosis is a disease that causes fatty deposits to build up and eventually clog arteries. This serious condition gradually reduces blood flow and oxygen to cells.

Atherosclerosis may eventually cause coronary artery disease, peripheral arterial disease, blood clots, heart attacks, or strokes. It’s currently the leading cause of death in the developed world.

Since 2013, Tasigna products sold in Canada come with a warning of the drug’s connection to atherosclerosis. This label change came after Canadian health officials warned that 277 cases of atherosclerosis were allegedly reported worldwide. Lawsuits allege that Novartis never warned of the risk of atherosclerosis in the U.S. though, despite these reports.

Other serious complications recognized by the FDA that may be linked to Tasigna include low blood cell counts; decreased blood flow to the heart, lungs, or brain; pancreatitis; and Tumor Lysis Syndrome, a condition that can occur when cancer cells are broken down quickly, resulting in kidney failure or an abnormal heartbeat.

Heart Complications After Taking Tasigna?

Some patients who took Tasigna and subsequently suffered a heart or circulation problem have filed lawsuits against Novartis. The lawsuits allege Novartis failed to properly warn of these side effects.

If you or a loved one suffered a heart or vascular condition like a heart attack, stroke, or atherosclerosis, you may be entitled to compensation. A lawsuit may help you recover compensation for medical bills, lost wages, pain and suffering, and more.

Our class action attorneys have stood up to the largest pharmaceutical companies in the country, and have the skills and resources to take on Novartis. To date, we’ve recovered $5 billion for our clients.

Contact us today for a free, no-obligation case review. It never costs a thing unless we win a verdict or earn a settlement on your behalf.