Tasigna, a common drug used to treat chronic myeloid leukemia (CML), has been linked to an increase atherosclerosis risk factors during treatment, according to at least a dozen studies reviewed from around the globe.

The atherosclerosis risk factors are reportedly linked to the medicine’s tendency to cause the walls of the arteries to swell. The inflammation narrows the interior diameter of the body’s blood delivery system decreasing the amount and speed at which organs and limbs receive life-giving oxygen and nutrients.

The atherosclerosis risk factors over time can cause undue strain on the heart which ramps up the effort to deliver. The reduction in blood supply to the extremities, organ systems, and brain can cause a cascade of physical problems, one of which is the possibility of non-fatal or fatal heart attack and/or stroke. Patients may also face an increased likelihood that limb tissue will die and require amputation through the development of peripheral artery disease (PAD).

When Tasigna was first approved by the U.S. Food and Drug Administration in 2007 for the treatment of CML, medical professionals and patients were not yet warned through appropriate labeling information of the drug’s tendency to increase atherosclerosis risk factors over time, according to plaintiffs in several lawsuits.

Novartis, the drug’s manufacturer, did place a black box warning on the medication, however, that alerted doctors and patients of the possibility that heart rhythm might be affected allowing for heart attack.

While Tasigna labeling in the U.S. did not at first warn about atherosclerosis risk factors, Novartis had changed the Canadian label as far back as 2013. This action reveals that Novartis has had knowledge of these side effects. As measured in 2016, Tasigna brought in nearly $1.7 billion in annual sales.

Tasigna Studies

The first study linking atherosclerosis risk factors and Tasigna was completed and had its data published in 2011. The results of this study indicated that roughly one-quarter of the enrollees were noted to have some compromise to their vascular system during treatment. Sixteen percent of participants developed PAD while taking the drug.

Close to ten other studies were published by 2013. Among them was an investigation by the FDA reviewing post-market adverse event reports which correlated the cancer medication with PAD. It wasn’t until this connection was officially publicized that the FDA required Novartis to add atherosclerosis risk factors to the warning section of the medication’s label.

Novartis allegedly aggressively marketed the cancer drug as a superior choice of treatment since its commercial inception in 2007. This went on even after the Canadian label change and before the label change in the U.S.

If you have suffered a heart attack, stroke, PAD, amputation, infection, or hardening of the arteries after taking Tasigna for CML, you could qualify to participate in a free Tasigna lawsuit investigation.