Tasigna: Atherosclerosis-Related Diseases
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Tasigna (nilotinib) was approved by the FDA in 2007 for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). Tasigna has been linked to atherosclerosis, which is a disease that results in thickening, hardening, and blocking of the arteries due to the buildup of plaque. In turn, strokes, heart attacks, and lower limbs amputations can be Tasigna side effects as these are serious medical conditions that can result from, or are secondary to, atherosclerosis-related diseases.
For whatever reason, in Canada the drug company Novartis Pharmaceuticals has issued stronger warnings about atherosclerosis-related diseases being Tasigna side effects — compared to what is found on the US version of the Tasigna drug label. This situation has given rise to the contention that warnings about Tasigna side effects in the current US drug label are insufficient, or a failure to adequately warn. In turn, drug injury products liability lawsuits have been filed against Novartis.
Some Atherosclerosis-Related Diseases
In more detail, the following medical conditions are considered to be atherosclerosis-related diseases:
- peripheral arterial disease (PAD) involving lower limbs;
- peripheral arterial occlusive disease (PAOD);
- ischemic heart disease; and
- ischemic cerebrovascular disease.
Resulting Tasigna Side Effects
Due to the nature of these conditions, they can result in serious injury and even death due to Tasigna side effects such as:
- Strokes / Cerebrovascular Accidents (CVA)
- Heart Attacks / Myocardial Infarctions (MI)
- Lower Limbs Amputations
- Aneurysms, e.g., Brain Aneurysm
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)
- Chronic Kidney Disease
- Kidney / Renal Failure
We are currently investigating Tasigna side effects cases as possible drug injury lawsuits against Novartis for patients who have developed any of the medical conditions listed above during their use of Tasigna.
We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.
Most Recent Article About Tasigna
A Letter to the Editor published online April 22, 2013 by the medical journal Leukemia, written by Ayalew Tefferi, MD, of the Mayo Clinic’s Division of Hematology, serves to present the various findings that had been discussed in the medical literature about the atherosclerosis side effect associated with Tasigna (nilotinib) no later than April 2013.
We selected this particular Letter to the Editor to review because it was during April 2013 that Novartis Pharmaceuticals Canada Inc. took these actions:
- Sent a so-called “Dear Doctor” letter in Canada (but not the US) warning about some serious side effects associated with Tasigna; and,
- Issued a Tasigna drug label change in Canada (but not the US) with new information concerning those Tasigna side effects.
In his Letter, called “Nilotinib treatment-associated accelerated atherosclerosis: when is the risk justified?”, Dr. Tefferi primarily commented on an earlier article which had been published online by Leukemia in March 2013.
To read more of this article, click below:
That earlier article, by TD Kim and several others, was titled “Peripheral artery occlusive disease in chronic phase chronic myeloid leukemia patients treated with nilotinib or Imatinib.” In summary, it reported the prevalence of PAOD in tyrosine kinase inhibitor (TKI)-treated patients with chronic myeloid leukemia (CML).
Dr. Tefferi started his Letter by setting the stage, so to speak, in this manner:
Atherosclerosis is the leading cause of death and morbidity in developed countries and is the culprit behind coronary artery disease (CAD), cerebral vascular disease (CVD) and peripheral artery occlusive disease (PAOD). Atherosclerosis leads to segmental narrowing and occlusion of arteries….
Later, Dr. Tefferi makes this relatively strong statement, which probably gave rise to the caption attributed to this April 2013 Leukemia Letter to the Editor by Tefferi:
Taken together, the above observations strongly implicate [Tasigna (nilotinib)] therapy as being proatherogenic. Regardless of what the underlying mechanisms for this might be, the question is whether or not it is necessary or appropriate to subject newly diagnosed patients with CP-CML to this risk [of atherosclerosis associated with Tasigna (nilotinib)], considering the remarkable efficacy and safety of imatinib therapy.
In closing this article, I will point out that in the US there still has not been any “Dear Doctor” letter sent nor any Tasigna drug label change made by Novartis Pharmaceuticals Corporation regarding atherosclerosis, despite the actions taken by its Canadian counterpart during April 2013.[Read article in full at original source]
Earlier articles by attorney Tom Lamb on the Side Effects Blog: