In 2013, the Swiss drug manufacturer Novartis issued an additional side effect to the warning label of its leukemia-treating chemotherapy drug Tasigna, claiming that it could cause arteriosclerosis. The warning of the potentially deadly cardiovascular side effect was issued to Canadian consumers, but not to Americans.
Major research on Tasigna and its association with atherosclerosis, also known as atherosclerosis, was published in the American Journal of Hematology in 2011. The researchers found that 25 percent of patients experienced vascular problems as a result of the drug, while 16 percent suffered from peripheral arterial disease.
What is Tasigna?
Tasigna is an oral chemotherapy drug used to treat Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Approved by the FDA in 2007, it was designed to interfere with the growth and spread of cancer cells in the body.
Tasigna and Arteriosclerosis
According to Medline Plus, arteriosclerosis is a disease in which plaque builds within arteries, limiting the flow of oxygen-rich blood to the body. Arteriosclerosis doesn’t show signs or symptoms until it severely or totally blocks an artery, usually causing a medical emergency.
Atherosclerosis has been linked to:
- Blood clots
- Coronary heart disease
- Chronic kidney disease
In Canada, Tasigna's label included a warning for atherosclerosis and other similar conditions. The U.S. label still doesn't warn Americans of the risks.
“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.”
In 2015, Novartis settled a federal lawsuit in the United States over claims that they illegally marketed drugs, including Tasigna. The manufacturer was also accused of giving kickbacks to pharmacies to recommend Tasigna to leukemia patients. The manufacturer paid $390 million to settle the case.