Study results show that patients treated with Tasigna may experience CML treatment side effects including atherosclerosis and other cardiovascular conditions.

Tasigna (nilotinib) is a chemotherapy drug used to treat chronic myeloid leukemia (CML) which was developed by Novartis and approved by the U.S. Food and Drug Administration (FDA) in 2007. The drug works to prevent the spread of cancer by blocking chemical enzymes involved in the growth and division of cancer cells.

Tasigna has become one of the most popular cancer drugs in the world and brought in sales over $1.7 billion for 2016. However, the drug may lead to adverse CML treatment side effects.

Some Tasigna CML treatment side effects were listed in a black box warning which has been included since the drug’s approval in 2007. However, other CML treatment side effects including atherosclerosis were not originally listed, leaving thousands of consumers potentially at risk.

Atherosclerosis is a condition involving a buildup of plaque in the arteries, causing the arteries to thicken and harden. This can compromise blood flow through the artery, leading to a variety of further complications including peripheral arterial disease.

Peripheral arterial disease involves compromised blood flow in the peripheral limbs, often occurring in the legs. Lack of circulation can lead to severe irreversible CML treatment side effects including infections, tissue death and possible limb amputations.

Other CML treatment side effects associated with Tasigna may include coronary artery disease, stroke, heart attack and death.

In 2011, the first major study was published which showed that atherosclerosis may be among CML treatment side effects. The study found that 25% patients experienced vascular problems while treated with Tasigna and 16% experienced peripheral arterial disease.

Since the 2011 study was published, over a dozen studies have provided evidence supporting the link between atherosclerosis and Tasigna treatment. In 2013, nine studies were published including an FDA postmarket review.

The FDA reviewed data from studies in the United States, Europe and Canada and concluded that findings “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease).” A warning was later added to the Tasigna label to inform consumers of the risk for atherosclerosis.

Despite the conclusion that Tasigna is associated with an increased risk of atherosclerosis, no FDA warning was issued to Novartis although the label was updated. However, in 2013 Novartis was issued a warning by Health Canada.

The Health Canada CML treatment side effects warning stated that atherosclerosis was detected in clinical trials and postmarket reporting. The warning encouraged doctors and health professionals to monitor for any signs of atherosclerosis and CML treatment side effects in Tasigna patients.

Some consumers claim that Novartis, Tasigna’s manufacturer, knew or should have known that their chemotherapy drug was associated with atherosclerosis and other CML treatment side effects. Instead of warning consumers of the risks for CML treatment side effects, Novartis allegedly started an aggressive marketing campaign to advertise Tasigna as superior to other chemotherapy treatments.

In 2015, Novartis faced a lawsuit accusing the company of illegal misbranding and promotion through the use of monetary kickbacks. The lawsuit was resolved with a $390 million settlement between Novartis and the U.S. Department of Justice.