Did Novartis Know About Tasigna Dangers?

Some patients who are treated with the drug Tasigna are questioning when the drug maker knew it could cause patients to develop a rapidly-progressing, irreversible form of atherosclerosis. These patients are using the legal system to help them get answers to their biggest questions. They are filing Novartis Tasigna class action lawsuits that allege the drug maker knew that patients treated with Tasigna faced increased risks of developing an insidious form of atherosclerosis.

About Tasigna Lawsuit Allegations

Two of the most important questions patients are asking is when the drug maker Novartis knew or should have known about the increased risk of atherosclerosis for patients treated with Tasigna, and why the medical community and their patients were not warned of the risk.

Tasigna was approved for use in the United States in 2007 and in that same year, adverse event reports were received by the Food and Drug Administration. Soon after, studies were conducted that found an association between the use of Tasigna and peripheral artery disease. Further investigations and studies found that of the 159 patients studied in 2013, 26 percent on first-line Tasigna, and nearly 36 percent of second-line patients developed peripheral artery disease. A second study involved 34 patients and showed that after two years, more than 26 percent of them developed peripheral artery disease and at least 17 percent of them needed surgical intervention or extended hospital stays.

But by then, nearly 4,500 adverse event reports had been filed with the FDA. Still, the drug maker did not warn patients or issue a drug recall to prevent more patients from experiencing this adverse event. At least the company didn’t in America. Novartis did warn patients and doctors in Canada about Tasigna’s association with atherosclerosis. The company issued two warnings, in fact, one directed at patients and another directed at doctors so that informed decisions could be made about treatment options and whether the risks of rapidly progressing atherosclerosis outweighed the potential benefits of the drug. In fact, Novartis warned Canadians about the risks of Tasigna on the Health Canada website, in physician reference documentation, consumer information brochures, and on the Novartis Canada website.

But patients in the United States never received the same types of warnings, even while the FDA was being flooded with adverse event reports. By 2018, more than 13,100 adverse events had been filed with the FDA including 9,174 cases of serious injuries, and 2,438 reports of patient deaths.

Tasigna Injury Lawsuits

Lawsuits are being filed across the country on behalf of patients who say they were not adequately warned about the dangers of Tasigna including about its severe and potentially catastrophic side effects. The plaintiffs in these cases want to know why they were not warned and denied the same opportunities as patients in Canada to make informed decisions.

Patients and the families of patients who died from atherosclerosis-related conditions are asking why the drug was marketed and promoted as a safer alternative than other treatments that do not cause rapidly progressing atherosclerosis or peripheral artery disease, coronary artery disease, and carotid artery disease, and amputations, heart attack, stroke, and death.