Canada, Not U.S., Receives Official Warning About Tasigna Atherosclerosis

The FDA approved Tasigna (nilotinib) in 2007 for the treatment of chronic myelogenous leukemia (CML). A few years later, however, studies revealed a link between patients taking the medication and atherosclerosis, a progressive narrowing of the arteries and blood vessels that can lead to heart attack and stroke, among other complications.

In 2013, manufacturer Novartis, together with Health Canada, issued a public warning about the risk, noting that cases of atherosclerosis-related conditions had been reported during clinical trials and post-marketing experience with the use of Tasigna. At the time, Novartis did not issue a similar warning in the U.S., however, leaving many patients and doctors unaware of the risk. Meanwhile, Novartis continued to profit off the drug while downplaying its side effects.

Studies Link Tasigna to Increased Risk of Atherosclerosis

Starting in 2011, studies began to reveal a link between Tasigna and atherosclerosis. One published in the American Journal of Hematology found an association between nilotinib and adverse vascular events, including severe peripheral artery disease (PAD), sudden death, heart attack, and subdural hematoma.

Researchers advised doctors to “stick with imatinib as front-line therapy for chronic myelogenous leukemia.” Imatinib is the generic name for Novartis’s earlier CML drug, Gleevec. Gleevec was a successful treatment for patients, but the patent expired in 2015, allowing generic versions onto the market.

In a 2013 article published in Leukemia, researcher Ayalew Tefferi referred to a study reporting the presence of peripheral artery occlusive disease in CML patients treated with both Gleevec and Tasigna. Those treated with Tasigna were at a much higher risk for the disease. More specifically, they found that 6.3 percent of those receiving Gleevec as a first-line therapy had peripheral artery occlusive disease, whereas 26 percent of those receiving Tasigna had the disease. The author questioned whether it was necessary to subject newly diagnosed patients to this risk, and suggested doctors stick with Gleevec as a first-line therapy.

In a 2016 study, researchers again linked Tasigna with atherosclerosis, noting that there were more cardiovascular events in patients receiving nilotinib than imatinib, and that elevations in blood cholesterol and blood glucose levels were also more frequent with nilotinib-use.

Only Canada Receives Official Warning About Tasigna Atherosclerosis

Novartis updated its black box warning in 2013 to include atherosclerosis, but never made a public announcement in the U.S. about the change.

In their warning issued in Canada, Novartis noted that between 2005 and 2013, they received a total of 277 reports of cases of atherosclerosis, including peripheral arterial occlusive disease, femoral artery stenosis (hardening and narrowing of the arteries in the upper thigh), coronary artery stenosis (hardening and narrowing of the arteries supplying the heart), carotid artery stenosis (hardening and narrowing of the carotid artery in the neck), and stroke.

Canadian doctors were advised to monitor patients taking Tasigna for signs of atherosclerosis, and to check both cholesterol and blood sugar levels before starting treatment and periodically thereafter.