A class action investigation has been launched against Novartis Co. after numerous patients reportedly developed serious complications from their Tasigna medication. Tasigna medication is specifically prescribed to patients suffering from chronic myeloid leukemia (CML) but has been linked to atherosclerosis in patient reports and multiple studies.

The Tasigna medication was approved by the FDA in 2007 and has since earned Novartis Co. billions in sales recorded at $2 billion in 2016. Even though the Tasigna medication has become widely popular and is an important treatment drug for CML patients, it has been recently linked with atherosclerosis, a condition in which the arteries harden and cause difficulties in the circulation system.

Tasigna (nilotinib) is specifically used for chronic myeloid leukemia cancer, which is slowly progressing bone marrow cancer that also affects red blood cells. CML is connected to an abnormal ‘Philadelphia’ chromosome, which causes the body making too many white blood cells. While Tasigna helps inhibit the reproduction of the cancer cells, the drug may compound the patient’s medical condition.

Overview of Tasigna Atherosclerosis Correlation

According to the FDA, while the Tasigna medication helps treat chronic myeloid leukemia, it may create the need for other medications to treat atherosclerosis and other similar complications. A post-market review from the FDA noted that recent research findings “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease).”

Over a dozen studies have linked the Tasigna medication to atherosclerosis have been published in medical journals in the United States, Canada, and Europe, with the first inquiry published in 2011. This study had found that 25 percent of Tasigna patients experienced cardiovascular problems and 16 percent suffered from peripheral arterial disease, soon after taking the medication.

Two years after the study was published, nine more Tasigna atherosclerosis studies were published in 2013. One of the studies was the postmarket review from the FDA after the agency reviewed injury reports submitted in the United States, as well as accounts from Canada and Europe.

After the FDA released its findings in 2013, Novartis reportedly updated the Black Box warning label of the Tasigna medication to include the potential development of peripheral vascular disease.

Atherosclerosis has been reported in patients who were prescribed the Tasigna medication on a long-term basis, in which plaque build-up is more likely and that the whole arterial vessel can swell and cut off circulation. Atherosclerosis is a condition in which the interior walls of the arteries thicken with plaque deposits, which impacts the circulation process.

These plaque deposits generally consist of fatty substances like cholesterol and calcium, which increases the chances of blood clots. The plaque buildup can eventually cause the arteries in the legs and arms to swell, which can compound into peripheral artery disease (PAD) and can cause the need for amputation in serious cases.

Other serious complications of blood clots in arteries can also include cardiac arrest, respiratory distress, stroke, and even kidney disease due to poor circulation. Patients who were prescribed the Tasigna medication and developed atherosclerosis or PAD may be able to file legal action against Novartis Co.

Patients can seek potential damages for negligence and failure to warn when the company was allegedly aware of this correlation years before the FDA released its findings.