The U.S. Food and Drug Administration approved leukemia drug Tasigna (generic name: nilotinib) in 2007. In 2015, however, the FDA revised Tasigna’s warning label to show the drug’s associated QT prolongation and sudden death risks. While sudden death warning is self-explanatory, some people may not understand what “QT prolongation” actually means. And for Tasigna patients, it’s vital to understand just how serious this risk can be for their long-term health outcomes.
Translating Tasigna’s QT Prolongation Warning Into Plain English
QT prolongation (also known as long QT syndrome) is a heart rhythm disorder that can cause seriously irregular pulse problems. A healthy person’s heart circulates blood throughout the body with every beat. To pump blood throughout your system, electrical impulses cause all four heart chambers to contract, then relax with every heartbeat. After every individual heartbeat, your heart’s “electrical system” recharges itself, preparing for the next one.
QT prolongation means it takes your heart much longer to recharge between beats, disturbing that natural electrical rhythm. In other words, people who have QT prolongation have fast, irregular heartbeats.
How Doctors Diagnose QT Prolongation Issues
An electrocardiogram (ECG) measures electrical impulses while they travel through your heart. A doctor typically puts patches with wires onto your skin to measure those electrical impulses.
ECGs measure electrical impulses in five distinct waves, labeled as P, Q, R, S and T. The Q through the T waves show the electrical activity in your ventricles (i.e., your heart’s two lower chambers). An ECG shows your doctor whether the QT interval occurs within a normal timeframe. If it takes longer than average, you have QT prolongation syndrome.
Potential QT Prolongation Health Dangers
For some, QT prolongation never causes any particular health problems. But stress (both emotional and physical) can alter any heart that experiences prolonged QT intervals. This causes your heart’s rhythm to spiral out of control, leading to life-threatening cardiovascular issues. Possible QT prolongation complications include:
- Heart attack
- Brain damage
- Sudden death
What Tasigna Users Need to Know About Irregular QT Intervals
QT prolongation is a very serious medical condition. While some people with it may be able to live normally, others may experience fainting, seizures, and even sudden death. If you have any preexisting heart conditions, including QT prolongation, hypokalemia or hypomagnesemia, Tasigna may harm you. Using any concomitant drugs that prolong the QT interval can make your condition even worse.
Even with no preexisting heart conditions, Tasigna carries significant side effect risks. Studies show Tasigna can prolong the QT interval in individuals with no preexisting risk factors and lead to serious heart conditions. Multiple studies show Tasigna patients may develop:
- Atherosclerosis
- Coronary artery disease
- Heart attack
- Cardiac arrest
A 2012 study states, “We present a case report of a male patient with CML who received nilotinib (Tasigna) therapy. He developed bilateral renal artery stenosis and renovascular hypertension. He had no history of hypertension, cardiovascular disease, or diabetes, and he was a nonsmoker.” (Emphasis ours.)
What Tasigna Patients Who Develop QT Prolongation Can Do
If you or a loved one experienced cardiovascular issues while taking Tasigna, we can help you get the justice you deserve. Despite extensive studies showing Tasigna’s heart damage risks, the drug’s manufacturer, Novartis, hasn’t issued any warnings. Injured patients are now filing failure to warn as well as wrongful death claims against Novartis nationwide.
To see if you may qualify for a cash settlement from the manufacturer, get your Tasigna compensation evaluation online now. Once you’ve submitted your information, an experienced advocate will call you to discuss your compensation options and possible next steps.
Related: Tasigna Removed From CVS, Express Scripts 2018 Drug Formulary Lists