Lawsuits Allege Safety Concern Over Novartis CML Drug Tasigna

A Novartis leukemia drug continues to be the subject of a handful of lawsuits filed by plaintiffs due to concerns over atherosclerosis-related conditions.

Tasigna was approved by the U.S. Food and Drug Administration in 2007 for the treatment of newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The medication belongs to a class of drugs called tyrosine kinase inhibitors (TKIs), which block a protein called Bcr-ABl to stop the growth of cancer cells. On the Tasigna website, there is a warning that the drug can cause a life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death, the black box warning on the website said. However, a number of lawsuits filed by patients accuse the medicine of causing "severe, accelerated and irreversible atherosclerosis-related conditions."

Atherosclerosis is a build-up of plaque in the walls of an artery that can cause a blockage of blood.

In the latest lawsuit, a Washington man represented by New York-based law firm Bernstein Liebhard LLP, said the patient had been taking another Novartis medicine, Gleevec, to treat his chronic myeloid leukemia. However, the patient’s oncologist switched him to Tasigna despite his leukemia being in remission. After the medication was switched the patient, 66, suffered from a stroke, according to a statement from the law firm. The patient had no history of atherosclerosis-related conditions. The lawsuit alleges that the Novartis medication "caused him to develop rapidly progressing atherosclerosis in his carotid arteries."

Since Tasigna’s regulatory approval, Bernstein Liebhard LLP said there have been several published studies that suggested: "patients treated with Tasigna may be more likely to develop arteriosclerosis-related condition." The legal firm linked to a 2016 study published in the American Journal of Hematology that linked Tasigna to an increased risk for peripheral artery disease and sudden death.

In a boilerplate on press releases regarding Tasigna Novartis does note that "cases of cardiovascular events included ischemic heart disease-related events, peripheral arterial occlusive disease, and ischemic cerebrovascular events have been reported."

Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, said in a statement that her firm has heard "from a number of patients" who allegedly experienced similar issues following dosing with Tasigna. In January Bernstein Liebhard LLP announced it was providing free reviews to potential Tasigna plaintiffs.

The legal firm noted that in 2013 Novartis updated its warning label for Tasigna sold in Canada that there is potential risk of arteriosclerosis. That warning, the firm said, is not on prescriptions sold in the United States.

While the legal firms are seeking to determine if the drug is related to the medical concerns of its clients, in December the U.S. Food and Drug Administration approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna product label. The update marked Tasigna as the first and only BCR-ABL tyrosine kinase inhibitor (TKI) to include data about attempting treatment discontinuation in eligible adult patients who achieve sustained deep molecular response of MR4.5, Novartis said in December.

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