Cancer drugs are notorious for their side effects. Since it’s extremely difficult to target only cancer cells, nausea, hair loss, and other unpleasant side effects are quite common. But popular leukemia drug Tasigna (generic name: nilotinib) may have some hidden side effects almost as dangerous as the cancer itself. Since winning the U.S. Food and Drug Administration’s approval in 2007, studies repeatedly found Tasigna can cause dangerous heart complications. Now, patients suffering from life-threatening Tasigna side effects are filing lawsuits against the drug’s manufacturer, Novartis AG.

Tasigna May Damage Patients’ Cardiovascular, Circulatory Systems

The most common Tasigna side effects are related to another complication that’s called atherosclerosis (hardening and narrowing of the arteries). Also known as coronary artery disease, rapid-onset atherosclerosis can lead to strokes as well as heart attacks. Among the most frequently reported Tasigna side effects are:

• Hardening of the arteries
• Coronary artery disease
• Heart attack
• Clogged/blocked blood vessels
• Leg pain/numbness
• Poor circulation
• Limb amputations
• Stroke
• Sudden death

Multiple studies on Tasigna side effects show patients at increased risk for developing atherosclerosis and experiencing vascular adverse events (VAEs). In fact, many study subjects reportedly showing serious Tasigna side effects had no heart issues listed in their medical history. A 2012 study states, “We present a case report of a male patient with CML who received nilotinib (Tasigna) therapy. He developed bilateral renal artery stenosis and renovascular hypertension. He had no history of hypertension, cardiovascular disease, or diabetes, and he was a nonsmoker.”

A 2011 study following 24 chronic myeloid leukemia patients found that 16% developed serious Tasigna side effects. Those three subjects showed “a rapidly progressive peripheral arterial occlusive disease (PAOD) during treatment with nilotinib (Tasigna).” Researchers concluded that “In all three cases, PAOD required repeated angioplasty and/or multiple surgeries within a few months.”

Experts Recommend Oncologists Screen for Risk Factors Before Prescribing Tasigna

Oncologists should pre-screen chronic myeloid leukemia patients for certain vascular risk factors to help them avoid life-threatening Tasigna side effects. That’s because comparable tyrosine kinase inhibitor (TKI) drugs exist for treating blood cancers without complications similar to Tasigna side effects. Still, patients with no history of heart problems or issues could still develop severe Tasigna side effects — including sudden death.

What FDA Warnings Say About Tasigna Side Effects

In 2010, the FDA expanded Tasigna’s approval to treat Philadephia chromosome-positive chronic myeloid leukemia (Ph+ CML). Novartis AG then updated the drug’s label to list sudden death and QT prolongation among other possible Tasigna side effects. The agency suggests patients diagnosed with pancreatitis, liver disease, hepatic impairment, electrolyte abnormalities and other risk factors avoid taking Tasigna. Interestingly, this updated 2010 label does not advise leukemia patients experiencing any cardiovascular symptoms to avoid or discontinue Tasigna therapy.

Lawsuits Say Novartis Didn’t Disclose All Tasigna Side Effects to U.S. Consumers

While the FDA hasn’t issued any Tasigna atherosclerosis warnings, patients suffering from serious cardiovascular events are now suing Novartis AG. Despite extensive studies showing increased heart damage risks from Tasigna side effects, Novartis didn’t issue an atherosclerosis warning in America. Novartis did, however, work with Health Canada in 2013 to warn that country’s consumers about potential cardiovascular Tasigna side effects. Kristi Lauris filed the first lawsuit against Novartis in 2016 after an allegedly Tasigna-induced stroke killed her father in 2014. Unfortunately, the Lauris family won’t be the last suing Novartis over Tasigna injuries — including wrongful death claims.