Tasigna medication has helped numerous patients with chronic myelogenous leukemia (CML), but it has also been linked with serious cardiac complications like atherosclerosis.

Tasigna medication is one of the primary treatment choices for this specific blood cancer, making its reported association with atherosclerosis very troubling.

Tasigna medication was approved by the FDA in 2007 with black box warnings for certain side effects. The warnings did not mention potential atherosclerosis or other related complications for at least several years, however.

Considering the drug’s popularity, it is important that patients and their healthcare providers understand the full scope of potential Tasigna side effects.

The troubling correlation between atherosclerosis and the Tasigna medication was eventually discovered after the FDA announced that it had conducted a postmarket review, which analyzed injury reports indicating a link  to atherosclerosis. The FDA postmarket review had reviewed injury reports from the United States, along with studies from Europe and Canada.

The FDA stated that its findings indicated “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease)”. In addition to the FDA review, over a dozen studies have been published with similar results.

The first study was published in 2011, which found that 25 percent of Tasigna patients had experienced vascular complications and 16 percent of patients had developed peripheral arterial disease.

Just two years later, nine additional studies were published that indicated patients faced an increased risk of developing atherosclerosis after taking the Tasigna medication. These studies were published in medical journals from the United States, Canada, and Europe.

Even with these studies published, atherosclerosis was reportedly not added to the Tasigna medication label until after the FDA announced the findings in 2013. Manufacturer Novartis had added atherosclerosis to the drug’s black box warning label, along with the development of peripheral vascular disease.

Overview of Tasigna Atherosclerosis Problems

Atherosclerosis is a life threatening condition in which the arteries become clogged or narrowed. This can lead to peripheral arterial disease (PAD), a condition that essentially causes the arteries to swell restricting circulation to the arms, legs, heart, brain, and other areas of the body.

If not treated promptly, PAD can cause patients serious cardiac complications, require serious treatment interventions like limb amputation, and even lead to death. It is important to note that PAD symptoms most commonly cause pain in the legs, but can also impact the arms, stomach, and head.

PAD related pain or cramping reportedly varies between patients, but appears between different levels of activity. Generally speaking, pain will appear during strenuous activities like walking or exercising because of the stressful movements. PAD can develop from atherosclerosis because the weakened artery muscles can break and cause a blood clot to form.

The development of a blood clot can further narrow the artery and can cause pain, sores, or ulcers if the clot becomes lodged in the peripheral arteries. This can eventually compound into total lower limb circulation loss possibly requiring amputation.

However the blood clot occurs in the carotid artery, patients could also potentially experience a stroke. Even though atherosclerosis is a potentially fatal complication, it was only recently added to the Tasigna medication warning label.

According to patients who have filed legal action over Tasigna medication, Novartis either knew or should have known about this potential complication, but failed to warn the general public.