Mounting Studies Link Tasigna to Arteriosclerosis, Other Dangerous Vascular Disorders

Published on May 17, 2018 by Laurie Villanueva

Tasigna, a medication prescribed to thousands of people to treat chronic myeloid leukemia (CML), has been linked to arteriosclerosis and other dangerous vascular disorders.

These findings have led to the filing of several Tasigna lawsuits that accuse Novartis AG of failing to provide patients and doctors with adequate warning of these potentially life-threatening side effects.

Tasigna: Background

Tasigna was approved by the U.S. Food & Drug Administration in 2007. Novartis considered the drug a replacement for Gleevac, another CML medication that had already proven lucrative for the company but which was set to lose patent protection in 2015.

Today, Tasigna ranks among the 10 top-selling cancer drugs in the world, with more than $1.7 billion in sales in 2016.

In 2013, Novartis entered into a $390 million settlement agreement with the U.S. Department of Justice and 39 other states to resolve charges that it had paid illegal kickbacks to specialty pharmacies to promote Tasigna. “Novartis incentivized and pressured the pharmacies to emphasize benefits to patients while understating the drug’s serious, potentially life-threatening side effects,” the Justice Department said in a statement announcing th­­­­­­e settlement.

Tasigna Arteriosclerosis Studies

Since its launch, several studies have suggested that patients who take Tasigna are more likely to develop arteriosclerosis or other life-threatening vascular conditions:

  • 2011: A study published by the American Journal of Hematology  involved 24 patients who were taking Tasigna to treat CML, 3 of whom went on to develop peripheral artery disease or other vascular disorders. None of the subjects had a prior history of peripheral artery disease before they began taking Tasigna.
  • 2012: A study published in the medical journal Blood reported that 4 out of 27 patients who had taken Tasigna for roughly 2 years as either a first or second-line treatment for CML had been diagnosed with peripheral artery disease or experienced other vascular occlusive events, including one who had a heart attack.
  • 2013: A paper published in Leukemia reported that patients taking Tasigna were more likely to experience peripheral artery disease compared to those taking Gleevac.
  • 2013: A second Leukemia study reported similar results.
  • The Canadian Tasigna label was modified after a Health Canada analysis revealed that 277 cases of arteriosclerosis had been reported to the Novartis Global Safety Database in relation to Tasigna between January 1st, 2005 and January 31, 2013.

What is Arteriosclerosis?

Arteriosclerosis is a condition in which fatty plaque collects in arteries, causing these vital blood vessels to narrow and harden.  This restricts blood flow to other parts of the body, including the limbs and vital organs.

Complications associated with arteriosclerosis include:

  • Peripheral artery disease
  • Coronary artery disease
  • Heart attack
  • Stroke
  • Death

Tasigna Lawsuits

At least two Tasigna lawsuits have been filed since March 2016 on behalf of patients who allegedly developed vascular disorders after they began taking the drug.

The first was filed in California federal court on behalf of man who died from complications related to arteriosclerosis shortly after he began taking the Tasigna in 2012.

A second Tasigna lawsuit was filed just this past February in Washington state federal court by a plaintiff who claims that the drug caused him to develop severe arteriosclerosis in his carotid artery, resulting in a stroke at the age of 66.

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