Experts say the long term side effects of Tasigna can include vascular problems like atherosclerosis.

Tasigna is a popular prescription drug used to treat chronic myeloid leukemia, a type of cancer that starts in the blood-forming cells in bone marrow and can spread over time. Tasigna is also known by its generic name, nilotinib.

Tasigna is made by the drug manufacturer Novartis, and was approved by the U.S. Food and Drug Administration in 2007. Since its approval, it has become one of the most popular cancer drugs, and has garnered over $1.7 billion in sales in 2016 alone.

Despite its popularity for treating chronic myeloid leukemia, the drug may pose serious dangers in the form of vascular side effects.

According to studies, use of Tasigna is linked to serious artery diseases including atherosclerosis. Atherosclerosis is a condition in which the walls of arteries thicken and harden from the buildup of plaque. Atherosclerosis can, in turn, cause other serious problems like vascular disease, peripheral artery disease, stroke and heart attacks.

If atherosclerosis develops into peripheral arterial disease (PAD) and circulation is hindered so much that blood cannot flow through the blocked arteries, patients can lose blood circulation in parts of their body. This can cause Tasigna patients to develop gangrene, or require amputation of limbs that have not gotten enough circulation.

Patients Claim No Warnings of Long Term Side Effects of Tasigna

Though the conditions linked to Tasigna can be life-threatening, many patients say that they were not warned that the long term side effects of Tasigna could include atherosclerosis or other cardiovascular problems.

Warnings associated with drugs should list all of the possible side effects or associated complications. But sometimes, that’s not the case, and patients unknowingly take drugs that can cause them serious injury. According to many patients, such was the case with Tasigna.

When the drug was released, and until 2015, the side effects listed on the drug’s label were things like pain, fatigue and constipation. Because of the severity of some of these side effects, the drug was given a Black Box warning, the most severe FDA warning issued.

Despite the Black Box warning, there was still no warning on the drug’s label about any cardiovascular side effects.

In 2015, Novartis, the drug’s maker, was hit with a lawsuit claiming that the company had misrepresented Tasigna as superior to other cancer drugs. The Tasigna lawsuit accused Novartis of illegally misbranding the drug and promoting monetary kickbacks to people who sold the drug. This Tasigna labeling lawsuit ended with Novartis paying a $390 million settlement to the U.S. Department of Justice.

After Novartis was accused of misrepresenting the drug as safer than it was, and after numerous patients reported that they had taken Tasigna and developed cardiovascular problems, the FDA required Novartis to update Tasigna’s label.

However, many patients say that Novartis knew that the long term side effects of Tasigna included atherosclerosis, peripheral arterial disease and other cardiac problems, but did not warn the American public.

In support for this claim, patients noted that Novartis issued a warning to Canadian patients in 2013 that the long term side effects of Tasigna included atherosclerosis.