Tasigna® (nilotinib) is a cancer medication manufactured by Novartis that was approved in the U.S. in 2007 for the treatment of Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML).
In April 2013, the prescribing information for Tasigna was updated in Canada after health officials warned that 277 cases of atherosclerosis had been reported worldwide between January 2005 and January 2013.
Atherosclerosis is a life-threatening artery disease that can cause narrowing of the blood vessels that carry oxygen-rich blood to the body. It is a risk-factor for blood clots, heart attack, stroke, and death.
Canadian health experts recommended that patients on Tasigna should be closely monitored for signs of arterial disease, but these warnings never trickled down to doctors in the U.S. or their patients.
In March 2016, the family of a man from California who died of atherosclerosis complications after taking Tasigna filed a lawsuit accusing Novartis of failing to warn patients in the U.S. about the risk.
According to the complaint:
Novartis’s failure to warn United States doctors and patients of the serious risks of developing atherosclerosis-related conditions associated with Tasigna was intentional, and part of an aggressive marketing strategy to sell Tasigna over competing TKI drugs.”
The plaintiff was prescribed Tasigna in 2012 for the treatment of leukemia. By September 2013, he had peripheral artery disease, a symptom of atherosclerosis, with 90-100% blockages in his legs.
His doctor read a medical journal article linking Tasigna and atherosclerosis and immediately switched him to another leukemia drug. He died of complications from atherosclerosis in March 2014.
Lawyers accuse Novartis of downplaying the risk of atherosclerosis to protect $1.7 billion in yearly sales of Tasigna. In 2015, Novartis paid a $390 million settlement to the U.S. Department of Justice for allegedly promoting Tasigna without adequate warnings about side effects.
The lawsuit was filed in the U.S. District Court for the Eastern District of California on March 22, 2016 — In RE: Lauris, et al. v. Novartis AG, et al. — Case No. 16-393.