Evidence is growing that Tasigna, a drug to fight cancer, is linked to atherosclerosis. This is a serious complication that can lead to fatal cardiac complications such as a stroke or heart attack. Lawsuits are being filed around the country and there is now an effort to certify a Tasigna MDL class action.
What is Tasigna?
Nilotinib, known by the brand name Tasigna, treats Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). It is a tyrosine kinase inhibitor (TKI). TKIs attack BCR-ABL1 proteins, which cause CML cell growth. They also block its functioning abilities, which kills the cells. Other TKIs include Bosulif, Gleevec, and Sprycel. Tasigna comes in tablet form. The Swiss-based pharmaceutical giant Novartis Pharmaceuticals manufactures and distributes it. Over 28,000 Americans have taken Tasigna since it was FDA approved in 2007.
Tasigna side effects
Tasigna may cause the following side effects:
- Elevated body temperatures
- Night sweats
- Stuffy nose
Atherosclerosis is a form of arteriosclerosis, a condition where the blood vessels thicken and harden. It occurs when plaque builds up in and on the walls. The buildup narrows the arteries. This results in decreased blood flow. It can also burst the artery, causing blood clots.
Other complications include coronary artery disease, carotid artery disease, periphery artery disease, aneurysms, and chronic kidney disease. Atherosclerosis severity varies on the affected artery. It can affect arteries in any part of your body.
Several medications treat this condition. They include statins, blood thinners, and blood pressure medications. If not treated early enough, atherosclerosis can cause heart attacks, strokes, or other medical issues.
2013 Health Canada alert
Fears about Tasigna have been out there for a long time. On April 12, 2013 – more than 7 years ago – Health Canada warned the public of Tasigna’s association with atherosclerosis-related conditions. It required Novartis Pharmaceuticals Canada to update its Tasigna information to include this risk. Health Canada made this announcement after a review of Novartis’ global safety database found that 277 Tasigna patients experienced atherosclerosis-related conditions between 2005 and 2013.
The agency advised patients to contact their healthcare provider if they suspect atherosclerosis-related conditions. It advised health care providers to check for atherosclerosis signs. Health Canada also advised them to check blood sugar and cholesterol levels before and during treatment.
2013 study on TKI associations with peripheral artery disease
In a June 2013 Leukemia-published study, researchers screened for peripheral artery disease (PAD) in Tasigna and Gleevec patients. Their data comprised 159 patients. The researchers found that 26 percent of Tasigna patients who took it as first-line therapy suffered PAD compared to 35.7 percent of patients who took it as second-line therapy.
By contrast, only 6.3 percent of Gleevec patients who it as first-line therapy suffered PAD. The researchers also found that Tasigna patients developed the condition within 21 to 56 months of taking the drug. They concluded that PAD was more prevalent in Tasigna patients than Gleevec ones. They advised healthcare providers to monitor and carefully assess PAD risk factors in their patients.
Novartis’ $390 million settlement
On November 20, 2015, Novartis Pharmaceuticals agreed to settle a lawsuit filed against them for $390 million. Over 40 states and the federal government accused the pharmaceutical giant of paying illegal kickbacks to specialty pharmacies. In exchange, the pharmacies recommended several of Novartis’ medications to Medicare and Medicaid patients, including Tasigna, Exjade, Myfortic, and Gleevec. Novartis asked them to recommend patients to continue taking its drugs and downplay their side effects. This lawsuit showed that the pharmaceutical giant put profits before patient safety.
2016 study on TKI associations with vascular events
Swedish-based researchers in an August 2016 Annals of Internal Medicine-published study investigated the vascular event incidence in TKI patients. Their data comprised Swedish patients who received a chronic phase CML diagnosis between 2002 and 2012. The researchers found that Tasigna and Sprycel patients were more likely to experience heart attacks compared to Gleevec.
Lauris v. Novartis AG
A woman filed suit in California federal court on March 22, 2016. She alleged that her husband’s taking of Tasigna caused him to die from atherosclerosis. The man was prescribed Tasigna for leukemia in 2012. One year later, he sustained peripheral artery disease. The man’s leg arteries were almost completely blocked. His physician stopped prescribing Tasigna and switched him to another drug. The man died from atherosclerosis complications the following year. His wife received an undisclosed settlement on November 6, 2018.
Tasigna MCL in New Jersey state courts
On February 9, 2021, the New Jersey state court’s Acting Administrative Director announced that the Supreme Court received a multi-county litigation application. It requested that over 60 pending Tasigna lawsuits be consolidated into an MCL that would be assigned to Bergen County. The plaintiffs in these lawsuits claimed to have sustained severe atherosclerotic-related conditions after taking Tasigna. They allege that Novartis hid the drug’s side effects from the public.
Tasigna lawsuit filed in New Jersey Superior Court
On February 17, 2021, a Virginia man filed suit in New Jersey Superior Court. He claimed he suffered atherosclerosis after taking Tasigna. The man received a CML diagnosis in 2006. He took Tasigna between 2008 and 2016. The man claimed the drug caused him to suffer coronary artery disease, peripheral vascular disease, and a stroke. His Tasigna lawsuit alleged that Novartis failed to adequately warn the public of Tasigna’s risks (more on that in a moment).
Tasigna lawsuits into an MDL class action
On April 14, 2021, a plaintiff filed a motion to transfer all federal Tasigna lawsuits into an MDL in Illinois federal court. At the time of filling, there were 18 pending federal lawsuits that spanned 12 jurisdictions.
The plaintiffs in these cases claimed to suffer atherosclerosis from taking Tasigna. They allege that Novartis failed to warn them and their healthcare providers of this side effect.
Tasigna and Failure to Warn
Ultimately, these are failure to warn cases. No one is arguing there should be a Tasigna recall. The drug has saved too many lives. The bigger question is should prescribing doctors and patients be advised of the risk so they can make an informed choice for themselves that is specific to their situation? This is what future Tasigna lawsuits will be all about.