Cancer is a harrowing ordeal of uncertainty, chemotherapy treatments and wondering if you’ll get through it at all. Once you reach that so-called light at the end of the tunnel called remission, you think you’ve made it and the worst is over.
For patients given Tasigna, post-treatment opens up a whole new door – one that’s nearly as terrifying as what you just went through. Researchers have linked this cancer drug, designed to treat chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML), with atherosclerosis, itself another life-threatening condition. As a result of manufacturer Novartis’ negligence in disclosing side effects, multiple patients and their families have started filing wrongful death lawsuits.
Background
The FDA approved Tasigna’s generic version Nilotinib in 2007, specifically for this purpose. Part of a drug class known as kinase inhibitors, Tasigna assists with treating a condition marked by an abnormal Philadelphia chromosome, which produces too many white blood cells. When this happens, the abnormal cells outnumber the body’s healthy white blood cells and eventually prevent them from functioning correctly. The cancer often ends up affecting both the blood and bone marrow.
Then, Tasigna blocks the Philadelphia chromosome’s blood cell-producing protein. While patients can take it in 400mg or 200mg doses, studies have linked it with multiple harmful side effects:
- Thickening of and blocking the arterial walls, leading to atherosclerosis.
- Plaque deposits in the arteries, leading to arterial blockage. With time, this condition develops into coronary artery disease, carotid artery disease, angina, peripheral artery disease or chronic kidney disease.
- Pancreas inflammation
- Bleeding in the brain
- Tumor Lysis Syndrome (TLS)
- Decreased blood flow, especially to the legs, brain, and heart.
- Low blood count, often accompanied by unexplained bleeding and weakness.
- QT prolongation
- Heart attacks
- Stroke
- Infection
- Tissue decay and necrosis
- Gangrene and amputations
- Sudden death
- Blood clots
Because of these conditions, Tasigna comes with a black-box warning listing sudden cardiac death as a side effect. Yet, atherosclerosis – the condition leading up to many of these side effects – isn’t included.
Controversy
In 2015, the patent on kinase inhibitor Gleevec – also owned by Novartis – was set to expire, thus giving other manufacturers the option to develop their own competing medications. Because this drug alone brought in $5 billion of annual revenue, Novartis began promoting Tasigna as a superior competitor, stating the drug was ideal for patients resistant or not responsive to imatinib treatments. In turn, the company directly paid specialty pharmacies to recommend Tasigna to Medicare and Medicaid patients filling prescriptions for imatinib and similar products and simultaneously downplayed the side effects, which multiple studies pointed out a few years before.
As a result, the U.S. Department of Justice filed a lawsuit against Novartis, alleging the drug manufacturer had been doing illegal kickbacks for this and five other medications. The company settled the charges for $390 million in 2015.
Yet, by this point, multiple researchers already pointed out the drug’s potentially life-threatening side effects:
- In 2011, the first study linking Tasigna use with atherosclerosis development found that up to a quarter of all users experience vascular issues and 16 percent have to manage peripheral arterial disease.
- In 2013, the FDA put out a post-market review of the drug, with data indicating a strong correlation between nilotinib (Tasigna) use and developing PAOD (peripheral arterial occlusive disease).
- Research published in 2013 in Canada, the U.S. and Europe identified a similar relationship. In response, Health Canada required Tasigna’s label to include atherosclerosis as a side effect and issued a statement to all healthcare providers. The statement indicated that up to six percent of all patients studied showed signs of arterial blockage and that Novartis’ global safety database listed 277 cases of atherosclerosis.
As of 2018, the FDA hasn’t made a similar move stateside and, as a result, the black-box warning doesn’t mention atherosclerosis as a side effect. Even with these findings, Novartis has announced plans to expand the drug’s scope to patients living with Parkinson’s and Alzheimer’s.
Lawsuits
While Tasigna has yet to go through a recall, patients or their surviving family members have individually started filing lawsuits against Novartis, alleging the drug manufacturer failed to warn them and medical professionals about its serious and potentially fatal side effects, intentionally concealed data and made unsubstantiated claims about the medication’s effectiveness.
Were you given Tasigna to treat this rare form of cancer, only to go through atherosclerosis or other adverse cardiac events afterwards? Don’t think you have to shoulder all the medical costs and stay silent. Trantolo & Trantolo believes in holding negligent drug manufacturers accountable for putting a dangerous product on the market and deliberately concealing information about its side effects. If you believe you have a claim, give our law firm a call today.
