Tasigna Case Study Links Cancer Drug To Increased Risk of Angina from Narrowing, Hardening of Arteries

A new case report highlights the side effects of Tasigna, a chronic myeloid leukemia (CML) treatment, which may cause a narrowing and hardening of arteries that increases the risk of angina.

Doctors from Japan detailed their experience with a patient who suffered angina, which was relieved by him being taken off Tasigna, according to findings published last week in the medical journal Cardio-Oncology.

Tasigna (nilotinib) was approved by the FDA in 2007, and is part of a class of medications known as kinase inhibitors, which are prescribed for treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) among recently diagnosed adults. It is marketed by Novartis for treatment of chronic phase and accelerated phase Ph+ CML in adults who are resistant or intolerant to prior therapy.

While the drug carries a “black box” warning about the risk of QT prolongation, which is a heart rhythm problem that can result in sudden death, Novartis faces a growing number of Tasigna lawsuits alleging the drug maker failed to adequately warn about the risk of blood flow problems, which may lead to atherosclerosis, a stroke, heart attack, amputations or death.

In this case, a 62-year-old patient with CML was being treated with 300 mg of Tasigna twice daily when he began complaining of rest angina, which is a type of chest pain which occurs due to a reduced blood flow to the heart. Many describe the sensation as feeling like their chest is being put in a vice.

The patient was diagnosed with vasospastic angina, and was at first treated with a calcium channel blocker and Nicorandil, which helped, but did not fully alleviate, the angina symptoms. Ten months later, he was still complaining about the chest pains.

Doctors then decided to cut his use of Tasigna in half, to 150 mg twice daily, which led to significant improvements, the researchers noted.

The researchers noted that cases of Tasigna-associated vasospastic angina are rare, but indicated they could be diagnosed by an acetylcholine (ACh) spasm provocation test. This could lead to faster treatment and prevent vascular events such as heart attacks, strokes and peripheral arterial occlusive disease, which has become “serious clinical problems” for patients taking Tasigna, and a similar drug, Iclusig.

“Cardiologists and hematologists should be vigilant for coronary artery spasm as a possible vascular adverse event caused by nilotinib,” the researchers concluded. “Careful long-term follow-up should be performed, especially in patients with CML with coronary risk factors.”

The findings come just weeks after all a panel of federal judges decided that all Tasigna cases will be centralized for pretrial proceedings as part of a multidistrict litigation (MDL) in the U.S. District Court for the Middle District of Florida.

Given common questions of fact and law raised in the complaints, one judge will preside over coordinate discovery and pretrial proceedings. However, if Tasigna settlements or another resolution is not reached, each individual case may later be returned to the U.S. District Court where it was originally filed for a separate trial in the future.

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