The FDA Atherosclerosis Warning Came Too Late for Tasigna Patients in the United States

Novartis warned Canadians of the atherosclerosis health risk of Tasigna while simultaneously increasing the sales of the drug in the billion-dollar US market

Monday, October 8, 2018 - Tasigna is a protein-inhibiting anti-cancer chemotherapy drug used to treat newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in the chronic phase in adult patients. Tasigna has been heralded for its cancer-fighting effectiveness and recently relabeled to the product to advise patients in remission that they may discontinue taking the drug upon receiving their oncologist's permission. In spite of the Tasigna's cancer-fighting effectiveness, Novartis surprisingly and urgently warned Canadians to steer clear of anti-cancer chemotherapy drug Tasigna by issuing an important safety notice.

Canadian health officials warned Canadians in an April 13, 2013 letter to the ministry of health Health Canada, of reports of Tasigna patients developing atherosclerosis-related diseases. The specific warnings stated that both pre-market and post-market clinical trials and experiences found cases of atherosclerosis and related diseases in patients taking Tasigna. The letter went on to urge doctors to test for the signs of atherosclerosis pre-treatment with Tasigna and to monitor patients receiving Tasigna on a regular schedule using blood testing and electrocardiograms (ECG). Tasigna patients experienced atherosclerosis-related diseases such as "peripheral arterial occlusive disease, femoral artery stenosis, coronary artery stenosis, carotid artery stenosis, and cerebrovascular accident."

In spite of the Canadian health warning, Novartis failed to warn cancer patients in the United States. As a result, thousands of Americans, thrilled to be cancer free, were faced with the equally as terrible disease, atherosclerosis, a hardening and thickening of the major arteries leading to the extremities, heart, and brain. Hundreds of people have been forced to undergo coronary bypass surgery to alleviate the blockages caused by the disease. Novartis continued to profit from Tasigna sales in the US for years after urging its discontinuation in Canada.

Studies have shown that patients were given Tasigna develop atherosclerosis, a narrowing of the major arteries leading to the extremities such as the feet and toes, as well as leading to the brain and heart. In the study approximately one-third of Tasigna patients required angioplasty to attempt to unblock their arteries, 22% required a stent placed in the artery to keep it open, and 22% required amputation of the toes, feet or lower legs. No warnings were made to the cancer community or government health officials in the United States. When eventually flooded with complaints, the FDA forced Novartis to place a boxed warning on bottles of Tasigna alerting oncologists and cancer patients about the risk of abnormal heart rhythm (QT prolongation) and sudden death. The FDA also warns Tasigna patients that the "Severe side effects of taking Tasigna include myelosuppression, blockages in the heart or arteries (cardiac and arterial vascular occlusive events)."

Novartis not only ignored their duty to warn US consumers of the atherosclerosis risk of Tasigna, but the company also redoubled their effort to sell the drug. Novartis sales reps illegally incentivized specialty pharmacists to push Tasigna and to ignore the drugs severe side effects, putting an unsuspecting cancer patient lives in grave danger. National Tasigna Atherosclerosis attorneys represent families and persons harmed by Tasigna.

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Lawyers for Tasigna Atherosclerosis Lawsuits

Attorneys handling Tasigna lawsuits for leukemia, non-Hodgkin lymphoma, and multiple myeloma offer free, no-obligation case review for individuals and families who believe they may have grounds to file a Tasigna lawsuit. Working on a contingency basis, these attorneys are committed to never charging legal fees unless they win compensation in your Tasigna lawsuit. The product liability litigators handling Roundup claims at the Onder Law Firm have a strong track record of success in representing families harmed by dangerous drugs and consumer products.