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Novartis Warned Canada, But Not the U.S., About Risks of Tasigna

In 2013, the Swiss drug manufacturer Novartis made a curious, but unfortunately all too common, decision regarding its Leukemia drug Tasigna. The company issued a warning to Canadian consumers advising them of potentially deadly cardiovascular side effects. The decision was curious because Novartis never issued any such warning to its U.S. consumers. It was common because drug manufacturers often decide to issue warnings in Canada and Europe well before they issue those same warnings to American consumers.

The Canadian label change was in response to a series of studies that linked Tasigna to atherosclerosis, a circulatory condition in which plaque builds up in the arteries and restricts the blood flow to the heart and organs. This is a serious condition that can lead to injuries such as:

  • Heart and vascular bypass surgery
  • Amputation
  • Stroke
  • Death

Tasigna is an oral chemotherapy drug used to treat Philadelphia chromosome-positive chronic myeloid leukemia. It was approved by the FDA in 2007.

Novartis added the risk of atherosclerosis to the Canada drug label in April 2013.

What Is Atherosclerosis?

According to the National Heart, Lung, and Blood Institute (NHLBI), atherosclerosis is a disease in which plaque builds up in the arteries. This can cause hardening and narrowing of the arteries, thus limiting the flow of oxygen-rich blood around the body.

Plaque is made up of fat, cholesterol, calcium, and other substances. The plaque causes the wall of the blood vessel to thicken and limits the amount of blood that can flow through the vessel to the rest of the body. Plaque buildup can also increase the chances of blood clots. A blood clot can partially or completely block blood flow. Depending on which arteries are affected, blood flow can be cut off from limbs or organs.

Diseases Caused by Atherosclerosis

Atherosclerosis can lead to other devastating diseases.

Coronary Heart Disease

If the plaque buildup happens in the coronary artery, the artery that supplies blood to the heart, then oxygen-rich blood to the heart will be limited. An individual may experience angina (heart pain and discomfort) or a heart attack if they are not receiving enough blood to the heart muscle.

Carotid Artery Disease

If the plaque buildup occurs within the carotid arteries, or the arteries located on the sides of the neck, then blood flow to the brain can be reduced. This can lead to dizziness, trouble speaking, severe headaches, and strokes.

Peripheral Artery Disease

When plaque builds up in the major arteries that supply blood to the legs, arms, and pelvis, it is called peripheral artery disease. If blood supply is limited to these limbs, an individual may need an amputation.

Chronic Kidney Disease

Plaque can also build up within the renal arteries. Renal arteries supply blood to the kidneys. If the kidneys do not have enough blood, they will not function properly. The kidneys are responsible for removing waste and excess water from the body.

The Health Canada warning reads:

“Novartis Pharmaceuticals Canada, Inc. (Novartis), in collaboration with Health Canada, would like to inform you about important safety information regarding reports of atherosclerosis-related conditions in patients treated with TASIGNA* (nilotinib).

TASIGNA* is a prescription medicine used to treat adult patients at different stages of a type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML).

  • Cases of atherosclerosis-related conditions have been reported during clinical trials and post marketing experience with the use of TASIGNA*.
  • Patients should tell their healthcare professional if they have or have had any conditions that could cause atherosclerosis-related conditions such as a heart problem, high blood pressure, high cholesterol, or high glucose before starting TASIGNA* treatment.
  • During treatment with TASIGNA*, healthcare professionals will check for signs of atherosclerosis. Healthcare professionals will also check cholesterol and blood sugar levels before starting treatment and periodically thereafter.
  • Patients should not stop treatment with TASIGNA* or change the dosage without discussing their condition with their healthcare professional.”

Over five years after this warning was issued, the drug label in the United States remains unchanged and silent regarding atherosclerosis. Those five years have not been without strife for Novartis. The company settled a federal lawsuit in 2015 over claims that Novartis illegally marketed drugs, including Tasigna. The company was also accused of giving kickbacks to pharmacies to recommend the drug to patients. It paid $390 million to settle that case.

Perhaps there is a reason Novartis continues to hide the deadly risks of Tasigna from American consumers?

It’s not right that Novartis has not warned U.S. patients about the risk of atherosclerosis. The company has been aware of this risk for years and has not given American consumers the information needed to make an informed decision on their healthcare. Contact GoldenbergLaw if you or a loved one was diagnosed with atherosclerosis while taking Tasigna. Help us hold them accountable.

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