Novartis' Failure to Warn the FDA May Have Led to Atherosclerosis in As Many As One in Four Tasigna Patients

Novartis has failed to officially warn cancer patients in the US that Tasigna can cause a disease even more deadly than cancer

Monday, November 12, 2018 - In 2011, scientists first discovered a connection between patients who take Tasigna, a potent and effective anti-cancer drug and atherosclerosis, a deadly narrowing of the blood's arterial passageways. Once aware of this research, Swiss pharmaceutical giant Novartis, maker of Tasigna, alerted the Canadian Health Ministry issuing an Urgent Field Safety Notice. Health Canada relayed the Tasigna/atherosclerosis connection to the Canadian people as follows: "In patients taking TASIGNA*, the following side effects related to atherosclerosis have been reported during clinical trials: peripheral arterial occlusive disease (hardening and narrowing of the arteries that supply blood to the arms and legs), femoral artery stenosis (hardening and narrowing of the arteries located in the upper thigh), coronary artery stenosis (narrowing or hardening of the arteries supplying the heart that causes angina (chest pain), carotid artery stenosis (narrowing or hardening of the carotid artery in the neck), and cerebrovascular accident (stroke). This Tasigna atherosclerosis warning was never given to government health officials and for years physicians were unaware of the connection. During this time, Novartis made billions in profits on US patients that were left in the dark. As a result, up to 25% of US Tasigna patients may have experienced "vascular events" according to post-market clinical data published by the American Journal of Hematology. To this day Novartis continues to downplay Tasigna's atherosclerosis side effects, never mentioning them to US health officials.

Novartis has taken steps to make people aware that Tasigna carries sometimes deadly side effects but for some, the warning is too little and for many, the warning came too late. Although Tasigna's packaging does urge doctors to perform an electrocardiogram prior to prescribing Tasigna, a warning of the specific atherosclerosis side effects never made it to a patient. Doctors believe that if a drug has been approved by the FDA, it must be safe. Without the bullhorn attention that an official FDA warning would generate, cancer doctors may not care if their patients develop heart disease from Tasigna. The attention of oncologists is laser-focused on treating cancer and look the other way as to any other conditions that a patient may develop. Oncologists argue that a patient would have died from cancer had they not taken Tasigna so what does it matter if they live longer and develop another disease down the road?

Tasigna has been shown to help a percentage of cancer patients suffering from chronic myeloid leukemia to go into remission and stay in remission for a period of years. Unfortunately, the Tasigna's toxicity attacks the smooth lining of the arteries and causes plaque to rapidly accumulate, narrowing the passageway through which the blood travels. When this occurs, necrosis tissue death of the extremities of the toes and feet can occur and the only treatment is amputation. Other times a chunk of plaque can break free from the arteries and become lodged in the smaller blood vessels and cut off circulation to the heart or brain resulting in a heart attack or stroke.

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