Colorado Product Liability Attorney
What is Tasigna?
Tasigna is an oral chemotherapy drug. It was developed by Novartis to treat a certain form of leukemia known as Ph+ CML.
Approved for use by the U.S. Food and Drug Administration in 2007, Tasigna has generated millions of dollars in sales for its manufacturer and is one of a class of drugs designed to block signals from abnormal proteins that produce cancer cells. Yet the drug also has several acknowledged and potentially serious side effects — and has been the target of lawsuits from patients who say they’ve suffered debilitating conditions from using the drug that the manufacturer failed to disclose.
Tasigna Side Effects
According to information provided by the FDA, common side effects of taking Tasigna include nausea, rash, headache, fatigue, itching, diarrhea, cough, constipation, joint pain, upper respiratory inflammation, fever, night sweats, and low levels of certain platelets and blood cells.
More severe side effects that can occur include blockages in the heart or arteries, inflammation of the pancreas, liver damage, metabolic abnormalities, severe bleeding, and fluid retention. Women who are pregnant or breastfeeding are advised not to take Tasigna because it may cause harm to a developing fetus or newborn.
In addition, the labeling for Tasigna contains a boxed warning to health care professionals and patients about the risk of developing an abnormal heart rhythm, known as a QT prolongation, and sudden death. Since Tasigna was approved for use, the FDA has received thousands of reports of possible adverse reactions, including more than 3000 deaths among Tasigna patients.
However, many of the lawsuits filed against Tasigna’s maker, Novartis, claim that the drug raises other health concerns not disclosed in its acknowledged possible side effects: that the drug may cause artherosclerosis, leading to heart attacks, stroke, or death.
Tasigna and Artherosclerosis
Artherosclerosis is a hardening and narrowing of the arteries, caused by the buildup of fats, cholesterol or other forms of plaques on the artery walls, leading to restricted blood flow. It is a disease that typically occurs over a long period of time and has been linked to obesity, an unhealthy diet, smoking, and other risk factors. But lawsuits filed against the maker of Tasigna claim that usage of the drug has led to accelerated and irreversible artherosclerosis in patients who had few or none of the usual risk factors associated with the disease.
In 2013 Novartis updated its warning label for Canadian sales of Tasigna to note a potential risk of atherosclerosis — a warning that was lacking from similar products sold in the United States. Some plaintiffs have cited research documenting “adverse vascular events” in Tasigna patients who had no prior history of vascular disease. The lawsuits against Novartis allege that the company failed to properly disclose the risk of artherosclerosis among those taking Tasigna.
The Dangerous Drug Lawyers at FDAzar
If you or a loved one has suffered from artherosclerosis or other cardiovascular conditions — such as blood clots, stroke, heart attacks, or peripheral artery disease—as a result of taking Tasigna, you may be entitled to compensation for your losses, including past and future medical bills, lost wages, and pain and suffering.
Call the experienced drug and medical device attorneys at Franklin D. Azar & Associates today for a free consultation and no-obligation evaluation of your case.