Tasigna Atherosclerosis Lawsuit News

Tasigna Black Box Warning Addendum

Tasigna has so many deadly side effects that an FDA Black Box warning merely scratches the surface

Friday, June 29, 2018 - Anti-cancer chemotherapy drug Tasigna is a kinase (protein) inhibitor used by adults for the treatment of chronic and accelerated Philadelphia chromosome-positive chronic myelogenous leukemia (CML). Tasigna's life-threatening side effects have prompted the Food and Drug Administration (FDA) to require the drug to include a Black Boxed Warning alerting patients of the potential for the drug to cause sudden death. According to www.walgreens.com, "A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug." The FDA has also determined that Tasigna's black box warning does not go far enough and urges oncologists to study the full warning PDF located at their website. (1)

Doctors are required to closely monitor Tasigna patients by performing an ECG (electrocardiogram) heart function evaluation before a patient receives Tasigna in order to screen out those with a pre-existing heart abnormality and also to serve as the baseline to compare future ECG's assessing the adverse side effects of Tasigna every 7 days. Other serious side effects from Tasigna listed alongside the Black Box warning include:

1. Myelosuppression - "A condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells, and platelets." The main symptom of myelosuppression is a decreased immune system compromising the body's ability to fight off infection. Patients with myelosuppression experience painful mouth sores and skin lesions that do not heal. (2)

2. QT Prolongation: An irregular heartbeat. Tasigna patients experience an increasingly irregular heartbeat that can in and of itself lead to a heart attack leading to sudden death.

3. Sudden Death - Tasigna patient may develop atherosclerosis and peripheral artery disease, a clogging of the arteries, that can lead to sudden death from a heart attack.

4. Other serious side effects include pancreatitis, liver function abnormalities, and electrolyte imbalances.

Overall, the theme of Tasigna's Black Box warning label and PDF addendum is that the drug causes atherosclerosis and peripheral artery disease that can lead to sudden death from a heart attack, paralysis from a stroke, and amputation of the toes, feet, and leg below the knee due to necrosis tissue death.

In 2013, prior to issuing a Black Box Warning and PDF addendum, Novartis, maker of Tasigna, warned Canadian health officials at Health Canada that Tasigna carried deadly side effects. Rapid-onset atherosclerosis was warned to be caused by using Tasigna and that doctors should screen their patients as well as monitor them during and after Tasigna treatments. While Canadian doctors were made aware of Tasigna's potential to cause atherosclerosis, no such warning made its way south to doctors in the United States where cancer physicians continued to give their patients Tasigna unabated. Tasigna patients that have been given Tasigna and have developed heart problems are advised to consult a Tasigna atherosclerosis lawyer to see if they qualify to file a claim against the company.

(1) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022068lbl.pdf

(2) https://www.cancer.gov/publications/dictionaries/cancer-terms/def/myelosuppression

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Lawyers for Tasigna Atherosclerosis Lawsuits

Attorneys handling Tasigna lawsuits for leukemia, non-Hodgkin lymphoma, and multiple myeloma offer free, no-obligation case review for individuals and families who believe they may have grounds to file a Tasigna lawsuit. Working on a contingency basis, these attorneys are committed to never charging legal fees unless they win compensation in your Tasigna lawsuit. The product liability litigators handling Roundup claims at the Onder Law Firm have a strong track record of success in representing families harmed by dangerous drugs and consumer products.