What is Tasigna?
Tasigna, also known by its generic name nilotinib, was first approved by the U.S. Food and Drug Administration in 2007 for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia (CML).
The drug was developed by the Swiss multinational pharmaceutical company Novartis to replace its cancer drug Gleevec. This was the previous generation drug used to treat CML and acute lymphocytic leukemia. In 2015, Gleevec generated $4.7 billion in sales around the world, but the patent for the drug expired that same year.
Novartis is currently looking to expand the uses of Tasigna beyond treatment of CML to include Parkinson’s and Alzheimer’s diseases after researchers found it helped a small number of patients with those diseases.
What is Chronic Myelogenous Leukaemia (CML)?
Philadelphia chromosome-positive chronic myelogenous leukemia (CML) is a form of cancer that affects the white blood cells. Side effects of CML include (but are not limited to):
- Stomach Pain
- Abdominal Swelling
- Night Sweats
- Weight Loss
- Bone Pain
- Enlarged Spleen
Because leukemia cells replace the bone marrow’s blood-making cells, other issues can arise from CML. This includes anemia, leukopenia, neutropenia, and thrombocytopenia
Prior to the advent of drugs like Gleevec, life expectancy was between 3–5 years after diagnosis. Survival rates drastically improved with the help of drugs. According to the National Cancer Institute, 2017 will see an estimated 8,950 new cases of CML and more than a thousand estimated deaths.
How Does Tasigna Work?
Tasigna is part of a class of drugs called tyrosine kinase inhibitors (TKIs). Tyrosine kinases are proteins that can stimulate cancer cells like leukemia to grow. Tasigna is designed to block a certain type of protein called Bcr-Abl. Inhibiting the protein stops the leukemia cells from growing.
The recommended dosing of the Tasigna pill is twice a day at 12-hour intervals on an empty stomach. It may also be combined with other drugs.
Common Tasigna Side Effects
Like most cancer treatment drugs, Tasigna comes with some side effects.
The most common side effects of the drug as listed on the prescribing information sheet include (but are not limited to):
- Night Sweats
- Pale Skin
- Runny Or Stuffy Nose
- Muscle And Joint Pain
Serious Tasigna Side Effects
More serious side effects can also occur to those taking Tasigna include (but are not limited to):
- Pancreas Inflammation
- Bleeding In The Brain
- Tumor Lysis Syndrome (TLS), Which Can Cause Kidney Failure
- Decreased Blood Flow To The Leg, Heart, Or Brain
- Low Blood Count That May Be Accompanied By Unexplained Bleeding, Blood In Urine, And Unexplained Weakness
- Atherosclerosis, Which Is The Hardening Of The Arteries
- QT Prolongation That Can Cause Sudden Death
Tasigna Linked with Atherosclerosis
A possible side effect currently not on the United States warning label for Tasigna is atherosclerosis. The life-threatening disease is when plaque builds up in the arteries, causing it to harden and narrow the pathways. This limits the flow of blood throughout the body and can lead to a host of other diseases and even death.
One of the first major pieces of research linking Tasigna with atherosclerosis was published in 2011 and found some patients taking the drug experienced vascular problems. Subsequent studies concluded that Tasigna was associated with accelerated atherosclerosis.
Those risks are one of the main reasons why patients are filing Tasigna lawsuits against Novartis.
Tasigna Lawsuits Claim Wrongful Death
The risk of atherosclerosis in patients taking Tasigna is not new. In 2013, Novartis and Health Canada released a public communication warning the public that cases of atherosclerosis-related conditions have been reported in clinical trials and post marketing experience for the drug.
According to the announcement, a global review between 2005 and 2013 found 277 cases of atherosclerosis with Tasigna. The safety information was added to the reference document for healthcare professionals in Canada and the Consumer Information Leaflet.
Despite that warning years ago, Novartis never issued a similar warning through the FDA to healthcare professionals and patients in the United States.
Now, Tasigna patients and their families are starting to file lawsuits looking for answers.
In March 2016, the family of a man in California who died from a disease associated with atherosclerosis after taking Tasigna filed a wrongful death suit against Novartis for failing to warn consumers about the dangers of the drug.
According to the complaint, Dainis Lauris was diagnosed with leukemia and was prescribed Tasigna for treatment. He developed atherosclerosis-related conditions and died. His family now says that Novartis sold and promoted the drug without warning about the risk of atherosclerosis to patients in the United States.
“Novartis did not send advisories to the United States public or to United States doctors. Nor did Novartis properly warn of the arteriosclerosis -related risks on the United States Tasigna label,” the complaint says. “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 family of Lauris contends that Novartis officials knew about the risk of atherosclerosis by at least 2011 but did not warn the public.
Novartis Settles Federal Tasigna Lawsuit in 2015
The wrongful death suit against Novartis isn’t the first time the company was targeted for Tasigna.
The drug manufacturer agreed to pay $390 million to settle federal and state charges over claims that it illegally marketed drugs, including Tasigna. Between 2007 and 2012, Novartis was accused of paying specialty pharmacies to recommend drugs to Medicaid and Medicare patients.
David Kester, a former sales manager, filed a whistleblower complaint under the False Claims Act. Novartis admitted to its knowledge of the scheme and said it would begin implementing new protocols with specialty pharmacies.