Though recent research has linked cases of atherosclerosis with the leukemia medication Tasigna, the drug’s U.S. label does not yet warn about that condition.

The Tasigna cardiovascular disease narrative is not unusual. In 2013, Canadian regulators required Tasigna’s manufacturer to update its label, warning patients about possible vascular side effects. For one reason or another, however, the FDA has yet to follow suit, and American patients continue to take the drug without a warning on the label about Tasigna atherosclerosis.

Tasigna is a popular cancer medication that is prescribed for the treatment of Philadelphia-chromosome positive chronic myeloid leukemia (CML). Research started to document a link between the drug and Tasigna cardiovascular disease as early as 2011.

Canadian authorities pushed the manufacturer Novartis, and the company finally added a label warning about Tasigna cardiovascular disease in 2013.

The warning concerning Tasigna cardiovascular disease included information regarding the potential to develop arteriosclerosis or “hardening of the arteries,” peripheral artery disease (PAD), and resultant tissue death leading to the need to amputate in some patients.

The label wasn’t changed in the U.S., however. Tasigna sold in the U.S. is not labeled with a warning about the risks of atherosclerosis, despite research showing up in several reputable professional medical journals.

The Complications Come on Suddenly

According to reports, the complications of Tasigna cardiovascular disease can occur with a rapid onset—giving little warning to the patient already dealing with a debilitating and life-threatening illness. Atherosclerosis causes an increase in white blood cells and fatty plaques to gather along the walls of the arteries.

This development could lead to cardiac or respiratory arrest. If this plaque breaks off and inhibits blood flow to the heart muscle, lungs, or brain, it could result in injuries like stroke or pulmonary embolism. These medical emergencies could lead to death.

As the narrowing of blood vessels increases, arterial blood flow is slowed by plaque to the arms, hands, legs, and feet. Death of tissue can result. When this happens, a patient may have to endure an amputation of the affected extremity—a horrifyingly disfiguring proposition.

Tasigna History

Tasigna was approved by the FDA for treatment of CML in October of 2007. According to estimates, Novartis raked in $1.7 billion in 2016 sales putting the cancer drug high on the list of popular treatment regimens globally. In the spring of this year, the medication was approved for pediatric use in chronic-phase CML patients over one-year-old.

If you or a loved one have endured Tasigna cardiovascular disease including arteriosclerosis, PAD, amputation or death, you might be eligible to file a legal claim against Novartis. A consultation with a knowledgeable Tasigna attorney can give you a clear idea of all your legal rights and options.