Tasigna (Nilotinib) is a tyrosine kinase inhibitor, which was approved by FDA for the treatment of imatinib-resistant chronic myelogenous leukemia on October 29th, 2007, and manufactured by Novartis. Further, on March 22, 2018, its usage was extended in adults and pediatric patients greater than equal to 1 year of age with a new diagnosis of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Tasigna has proven useful in pediatric patients with resistant or intolerant Ph+ CML-CP.
Gradually, it was observed that Tasigna, considered as a boon, started developing some fatal health conditions.
Tasigna is a kinase inhibitor that is said to work in the body by interfering with protein signaling cancer cells to multiply. This medication is used to treat adult patients who have been diagnosed with chronic myeloid leukemia. This drug is also effective in the treatment of Philadelphia chromosome-positive myeloid leukemia that can be chronic as well as accelerated. Tasigna comes along with side effects like skin rash, itching, headache, diarrhea, constipation, and minor cold symptoms.
The patients should immediately consult with the doctor if patients using Tasigna comes across severe side effects like painful urination, rapid weight gain, high blood sugar, and signs of liver disease.
Tasigna comes in the form of a gelatin capsule which has a strength of 150 - 200 mg. The dosage recommendation is usually twice a day which should be eaten one hour before eating food or two hours after having food. The physicians sometimes need to alter the dosage depending upon various health factors. Tasigna might interact with various other drugs, therefore doctors should be well informed about the other medication being taken by patients.
Pregnant women should stay away from taking Tasigna as unstudied risk can be pass on to the newborn baby while breastfeeding. There has been no establishment of Tasigna safety usage in pediatrics.
Patients need to note that while taking Tasigna they should avoid grapefruit and grapefruit juices as they interact with this drug and leads to unwanted side effects. Stomach acid reducers like Pepcid, Tagamet, or Zantac should be taken 10 hours before taking this medication or 2 hours after having the drugs. Also, an antiacid that contains aluminum like Di-Gel, Gaviscon, Maalox, etc should be taken two hours before or after this medication. Tasigna can cause severe heart problems to patients who are already taking medication for asthma, mental illness, high blood pressure, and depression.
A total of 16,478 patients in the US from 2007 to September 30, 2019, have reported Tasigna side effects. As per the FDA Adverse Events Reporting System (FAERS), 11,532 cases out of 16, 478 cases were serious that includes 3100 deaths.
Lawsuits have been filed against Tasigna’s manufacturer, Novartis, claiming that the company did not warn the public about atherosclerosis. This disease occurs when arteries are blocked by fatty deposits that may lead to strokes, heart attacks, and other chronic problems.
Patients who have achieved good blood cell counts can stop treatment. Doctors term this as treatment-free remission, or TFR. However, stopping Tasigna may lead to side effects.
Patients who go for TFR may have to encounter musculoskeletal problems after stopping Tasigna. The problems include pain in the muscles, joints, bones, legs, and spine. Patients who come across these complications should inform their doctor.
If we speak of atherosclerosis disease, it develops over several years, however, a paper published in Leukemia stated that patients developed accelerated atherosclerosis just two and a half years after taking Tasigna drug.
Tasigna medication also comes along with Myocardial ischemia which occurs when the heart does not get an adequate amount of blood flow. Atherosclerosis which affects the coronary arteries is one of the common causes of myocardial ischemia.
When the heart muscles do not get enough oxygen and blood, it leads to struggle in the functioning of the heart. This can lead to a heart attack. As per the clinical trial, 5 percent of patients taking 300 mg of Tasigna daily dosage suffer from ischemic heart disease, while 9.4 percent taking 400 mg of this drug suffer from this chronic disease.
Tasigna comes with a black box warning for the risk of QT prolongation and sudden death which is a condition that happens when there is an irregular heart rhythm. QT prolongation may cause consciousness or sudden death.
In the year 2013, Health Canada red signaled Canadians about the risk of atherosclerosis associated with Tasigna. The manufacturer of this drug, Novartis listed warnings to the Product Monograph that informed Canadian doctors about the usage of this drug. However, the company did not mention atherosclerosis disease risk in its packaging boxes in the United States.
Patients who have suffered atherosclerosis due to Tasigna medication may qualify to file a lawsuit for compensation. Currently, People may file injury cases individually as there is no class suit established as of now.
Tasigna lawsuits accuse Novartis has the allegation that the company failed to warn the consumer in the US about this drug risk linkage with atherosclerosis. The plaintiffs also accuse the manufacturer of illegal marketing, reckless conduct, fraud, allegedly failing to warn the consumer about the risk just for the sake of the company's profit and conscious disregard.