Tasigna, also known generically as nilotinib, is commonly prescribed to patients diagnosed with chromosome-positive chronic myeloid leukemia or CML. Although Tasigna can help with the treatment of CML, several studies have indicated Tasigna might cause severe and potentially life threatening side effects. If you or someone you love has been prescribed Tasigna and suffered vascular related side effects, don’t wait to speak with an experienced Tasigna attorney to learn about your legal options and to protect your rights.
The National Cancer Institute explains Chronic Myeloid Leukemia (CML) is a disease that causes the marrow in a person’s bones to make too many white blood cells. CML is treatable, but if it is left untreated it can cause chronic diseases. CML occurs during or after middle age and rarely affects children. According to the National Cancer Institute, approximately 8,900 Americans will be diagnosed with CML, and about one thousand will succumb to CML each year.
Under normal circumstances, the marrow in a person’s bones makes blood stem cells, which are essentially immature cells. These immature cells will mature over time and can become different types of blood cells, myeloid cells, and lymphoid cells. In CML patients, a disproportionately high number of immature cells mature into a white blood cell called a granulocyte, more commonly known as a leukemia cell. Leukemia cells can build up in the blood and bone marrow, reducing the amount of space available for healthy white blood cells, red blood cells, and platelets. When the body suffers from a decreased amount of any one of these health cells, conditions like anemia can occur.
When a patient has CML, too many blood stem cells become a type of white blood cell called granulocytes. These granulocytes (leukemia cells) are abnormal and do not become healthy white blood cells. They can build up in the blood and bone marrow so there is less room for healthy white blood cells, red blood cells, and platelets. When this happens, infection, anemia, or easy bleeding may occur.
Tasigna is in a class of drugs known as tyrosine kinase inhibitors (TKIs). Nearly all patients with CML have a genetic mutation called the Philadelphia chromosome, and this mutation causes a disproportionate number of abnormal leukemia cells to be produced in the body. Tasigna works by targeting and blocking the continued development of abnormal leukemia cells.
In 2011, a study published in The American Journal of Hematology noted that three patients taking Tasigna developed rapidly peripheral arterial occlusive disease (PAOD) while taking the drug. These patients eventually required multiple surgeries to treat the PAOD. Just two years later, an article published in the journal Blood looked at the outcomes of 34 patients receiving Tasigna and determined an increased percentage of patients suffered from arterial occlusive disease. After these studies, Health Canada released two safety alerts to warn patients and doctors “cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of Tasigna.”
One month after Canada issued safety alerts, an article in The American Journal of Hematology noted patients who suffered from Tasigna-related arterial disease also had an increased chance of suffering from rapidly progressing intra- and extra-cranial atherosclerosis that led to a stroke. One of the most recent studies suggesting a link between Tasigna and adverse vascular events was published in December 2015 in the journal Cardio-Oncology. Researchers looked at clinical trial data from the past ten years and concluded serious vascular side effects were being more frequently reported with newer generations of TKIs like Tasigna.
Like all medications, Tasigna does come with side effects. However, some patients experience severe complications, including:
A lack of blood flow caused by Tasigna can cause severe complications for patients. When the body doesn’t receive an adequate amount of oxygen, it can cause infections, tissue death, strokes, and even death.
Patients were not adequately warned of the vascular risks associated with Tasigna. Patients have a right to know all risks associated with medications before they take them so they can make informed decisions about their care. One Tasigna lawsuit has already been filed, and it very likely more will continue to be filed as patients experience dangerous side effects.
In the United States, a tort refers to a, “body of rights, obligations, and remedies that is applied by courts in civil proceedings to provide relief for persons who have suffered harm from the wrongful acts of others.”
An MDL stands for multidistrict litigation and is a special legal procedure conducted in federal court that is designed to quickly conduct the handling of complex cases, which can include dangerous drug and medical device lawsuits.
It means the manufacturer made an error either in the design or the fabrication of a product that causes it to not work as intended. This can be especially dangerous in many cases, such as those of faulty medical devices and prescription drugs.
A defective design in a product is one that is so great, the product cannot be utilized for the purposes intended or is even made hazardous as a result of the defect, imperfection, or design flaw. In the case of medical devices, this can be a deadly mistake.