If you have received Tasigna as a CML cancer treatment, you could be at increased risk of cardiovascular or circulatory problems.

Certain types of Chronic Myeloid Leukemia (CML) are often treated by Tasigna (nilotinib), a chemotherapy drug approved by the FDA in 2007.

Even though Tasigna carried other Black Box warnings, patients and their physicians in the U.S. did not receive notification that Tasigna could be linked to atherosclerosis, which is a clogging or narrowing and hardening of the arteries. The narrowed pathways can cause decreased blood flow to the extremities, heart, brain and other organs. Over time, the restricted circulation can result in severe cardiovascular issues, amputations, and even, death.

Left unchecked, atherosclerosis can become peripheral arterial disease (PAD). While PAD symptoms often are felt in the legs, the condition might cause issues with the arms, stomach or head. PAD victims develop cramps or tiredness in their leg or hip muscles when walking or climbing stairs. These symptoms subside when the patient rests, but return once the patient resumes activity.

CML Cancer Treatment Studies

Tasigna is a type of targeted chemotherapy treatment and belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs). Tasigna is a pill that is taken orally, and the drug identifies cancer cells while causing minimal damage to healthy cells. In CML cancer treatment, Tasigna blocks the abnormal protein that causes CML cells to grow. When the abnormal protein is blocked, the CML cells die.

Tasigna is approved as an initial therapy CML cancer treatment, which means it is the first therapy given for the disease.

More than a dozen clinical studies have found a link between Tasigna and atherosclerosis. In 2011, the first published study indicated a quarter of Tasigna patients developed vascular issues and 16 percent experienced PAD.

An additional nine Tasigna studies were published in 2013, including a postmarket review by the FDA. The FDA determined from its review that results “strongly suggest an association between nilotinib (Tasigna) and PAOD (peripheral arterial occlusive disease).” After the FDA’s findings were released, Tasigna added a warning regarding the risks of atherosclerosis to the CML cancer treatment’s label.

Now, Tasigna manufacturer Novartis could face lgal claims alleging the company knew of Tasigna’s dangerous side effects for year before the warning was added to the medicine’s label. Novartis allegedly participated in aggressive marketing and promotional campaigns to convince doctors and consumers that Tasigna was superior and more effective than its competitors.

Tasigna’s website now warns patients that they may experience a decrease of blood flow to the legs, hear or brain and should seek medical assistance immediately if they experience any of the following symptoms:

• Chest pain or discomfort
• Numbness or weakness
• Problems walking or speaking
• Leg pain
• Leg feels cold
• Skin color of the leg changes

If you or someone you love has undergone CML cancer treatment and experienced atherosclerosis or PAD, you could be eligible for compensation through legal means.