Tasigna (nilotinib) was approved by the U.S. Food & Drug Administration in 2007 to treat patients suffering from Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML). 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. Since its approval, several studies have suggested that patients treated with Tasigna may be more likely to develop arteriosclerosis-related condition. For example, a 2016 study published in the American Journal of Hematology linked Tasigna to an increased risk for peripheral artery disease and sudden death.
In 2013, researchers writing in Leukemia reported that patients treated with Tasigna had higher rates of arterial disease compared to those prescribed imatinib. The Canadian label for Tasigna was updated in 2013 to note a potential risk of arteriosclerosis, after a review revealed that 277 reports of the condition had been logged with the Novartis global safety database between January 1st, 2005 and January 31, 2013. Canadian doctors were advised to closely monitor their Tasigna patients for signs of the life-threatening artery disease.
Here is the link for the Canada label changes made in 2013:
Subject: Updated information regarding the possible risk of developing atherosclerosis-related conditions with the use of TASIGNA* (nilotinib)
Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).
TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML).
- Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
- Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
- During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professional will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
- Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.
Atherosclerosis is a disease that occurs in arterial blood vessels (arteries) and occurs more frequently in older adults. In atherosclerosis the walls of the arteries become thickened and hardened by plaque buildup. Plaque is made from fatty deposits and cells that can build up in the walls of your arteries over many years. As plaque builds up, the arteries narrow and become less flexible and the blood flow through the arteries can be reduced. Possible complications of atherosclerosis include heart attacks and strokes.
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/26659a-eng.php
