Facing Hundreds of Tasigna Lawsuits, Novartis Moves Forward with Clinical Testing

Pharmaceutical company seeks to expand FDA approvals for Tasigna despite Tasigna heart problems

Monday, October 23, 2017 - While one arm of the company is busy facing Tasigna atherosclerosis lawsuits in U.S. district courts, Novartis officials are seeking ways to further expand Tasigna‘s scope. Two clinical trials are currently underway in the United States, testing the effectiveness of Tasigna in halting brain deterioration in Parkinson‘s and Alzheimer‘s patients.

While a drug that could ward off brain cell degeneration would be a boon to medicine, American consumers have reason to be concerned. Novartis‘ track record in relation to clinical trials and drug safety transparency is poor, including major Tasigna side effects omissions and a $390 million penalty handed down through a Justice Department Tasigna lawsuit in 2015.

American consumers have never been officially warned of the risk of Tasigna side effects including peripheral arterial disease, atherosclerosis, and other heart problems from Tasigna. Yet many consumers are putting together the pieces on their own. A Tasigna warning issued in Canada outlined the warning signs of rapid-onset atherosclerosis. A Tasigna wrongful death lawsuit in California cited the warning, alleging the patient would have received proper treatment and could have been saved had the physician been alerted of Tasigna side effects.

Novartis has a track record of manipulating clinical study outcomes for Tasigna. In 2013, Novartis was issued misconduct charges in Japan for omitting 33 adverse event reports from a clinical study on Tasigna side effects. In fact, several executives were terminated after allegedly concealing information about the missing adverse event reports.

The new clinical studies were prompted by a small indication, from another study conducted at Georgetown University Medical Center, that Tasigna may have a positive effect in patients suffering from degenerative brain diseases. The original study gave some hope to researchers, yet did not include a control and is thus not reliable. The two studies, being conducted concurrently at Georgetown University this year, aim to determine whether Tasigna (nilotinib) is effective at slowing or halting brain cell damage in patients suffering from Parkinson‘s disease and Alzheimer‘s disease, respectively.

Researchers are operating on a theory that Tasigna turns on a mechanism in brain cells that degrades toxic proteins. While there is evidence to suggest Tasigna is effective at activating this cleansing mechanism, researchers aren‘t yet sure if the drug will be useful or safe for patients with brain disease. This would be the first drug found to be effective at halting the effects of diseases like Alzheimer‘s and Parkinson‘s.

The question of whether nilotibin is effective at slowing brain degeneration is only one piece of the puzzle. Determining whether the benefits outweigh Tasigna side effects is equally important. Tasigna is a strong cancer drug, the use of which has not been tested in patients with less aggressive disease. Based on current knowledge of Tasigna atherosclerosis, these clinical trials must carefully examine whether Tasigna risks are worth its benefits. Novartis has a vested interest in expanding the FDA approval of the drug beyond its use as a cancer treatment, and American patients and the medical community have reason to be wary.

Information Provided by The Onder Law Firm

The Onder Law Firm is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O‘Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm‘s attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The firm has represented thousands of persons in these and other products liability litigation, including DePuy hip replacement systems, which settled for $2.5 billion and Pradaxa internal bleeding, which settled for $650 million. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.

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