Tasigna, a medication used to fight a certain type of leukemia, has been linked to the development of arteriosclerosis and other diseases that compromise the cardiovascular system. This connection sparked a Tasigna lawsuit against the drug’s manufacturer, Novartis Inc.

This Tasigna lawsuit concerned the wrongful death of a California man in the spring of 2014, a chronic myeloid leukemia (CML) sufferer who succumbed to complications arising from constricted arterial blood flow. Dainis L., the decedent for whose estate this Tasigna lawsuit was filed, developed peripheral artery disease on the medication which led to almost complete blood flow blockage to his lower extremities.

The Tasigna lawsuit made a claim that Novartis was purportedly aware that nilotinib, the generic name for the CML medication, had cardiovascular risks associated with it many years before it changed its label to reflect growing concerns. If this allegation is correct, the drug’s maker could be held responsible for patients’ cardiovascular complications.

The Leukemia Drug’s History

Nilotinib or Tasigna was approved by the U.S. Food and Drug Administration (FDA) in 2007 to treat CML. It is part of a class of drugs known as tyrosine kinase inhibitors (TKI) which starve leukemia cells of Bcr-Abl—a protein necessary for their growth and reproduction.

Six years after approval in the U.S., members of the Canadian professional medical community were told to keep an eye on patients under treatment with Tasigna for arterial issues.

The Canadian label for the drug was changed simultaneously with this communication in 2013, due to a discovery of close to 300 arteriosclerosis adverse event reports noted on the manufacturer’s worldwide safety database. These adverse event reports were entered during an eight-year time window between January 2005 and January 2013.

A label change with warning was also made in the U.S. in 2013, but only after the data associated with several studies indicating a relationship between arteriosclerosis and related conditions with Tasigna use was released.

The FDA was one of the entities to publish a thorough review of database events, as well as scientific findings from Europe, Canada and the U.S.

Prior to that, it was up to the individual doctor in charge of different CML patients to be aware of cardiovascular risks of the drug through a professional review of medical journals that were slowly starting to report on the connection.

Such was the case with the physician caring for Dainis L., who upon reading a professional article, changed the medication being used to treat him. Unfortunately, this change came too late for his patient.

Tasigna garnishes significant revenue for Novartis still, with global profits exceeding $1.7 billion globally in 2016. Despite the 2016 Tasigna lawsuit and other lawsuits being currently filed, the drug manufacturer is looking to expand approved on-label treatment uses for Tasigna to include Parkinson’s disease and Alzheimer’s disease.