Tasigna (Nilotinib)
DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.
Tasigna (nilotinib) is a prescription medication used to treat a specific type of leukemia. Created by Novartis AG Pharmaceutical, a Switzerland-based pharmaceutical company, Tasigna received FDA approval in 2007.
Since then, many patients have suffered severe side effects from Tasigna. These side effects differ from those listed on Tasigna’s Black Box warning label, the FDA’s strongest warning label available for medications. Because of this, many patients may be eligible to file a claim against Tasigna for the side effects they suffered.
What Is Tasigna Supposed to Do?
Tasigna treats a specific kind of cancer known as Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). When a person suffers from Ph+ CML, their bone marrow produces too many white blood cells.
The median age of patients with Ph+ CML is 67 years old. Median survival used to be between only 4 to 6 years but now may be approaching normal life expectancy.
On a technical level, Tasigna is supposed to block chemical enzymes in cancer cells to prevent further cell growth and division.
Who Makes Tasigna?
Novartis AG Pharmaceutical produces Tasigna. As the manufacturer of one of the most popular cancer drugs worldwide, Novartis made $1.7 billion off of the drug in 2016.
Novartis doesn’t exactly have a clean record when it comes to encounters with the U.S. Department of Justice. In 2015, Novaris had to pay a $390 million settlement for illegal misbranding and promotion by monetary kickbacks as part of their aggressive marketing campaign for Tasigna.
What Are the Side Effects of Tasigna?
Tasigna causes severe and rapid-onset atherosclerosis. Atherosclerosis causes artery walls to thicken. This narrows the channel where blood can flow and causes improper blood circulation, leading to a condition called peripheral arterial disease (PAD).
PAD is severe and often irreversible. Patients with PAD may suffer:
- Infections
- Tissue death
- Limb amputation(s)
- Coronary artery disease
- Stroke
- Death
Tasigna also appears to cause other heart and circulation problems. In addition to the previously listed side effects, many patients have experienced the following vascular adverse events (VAEs):
- Hardening of the arteries
- Heart attack
- Clogged/blocked blood vessels
- Leg pain/numbness
- Poor circulation
Many patients who suffered these complications had never experienced any heart issues until they took Tasigna.
When Did Novartis Know About Tasigna’s Side Effects?
The first major study regarding Tasigna and atherosclerosis was published all the way back in 2011. It found that a whopping 25 percent of patients suffered from some type of vascular problem as a result of taking Tasigna. 16 percent suffered from PAD specifically.
Nine more studies were published in 2013, including one from the FDA. At the time, the FDA added a warning to Tasigna’s packaging regarding atherosclerosis.
Although the label was updated, the FDA failed to issue a formal warning. Because of this, many health professionals and patients were not made aware of the serious risks associated with taking Tasigna.
However, Canada’s governmental health agency, Health Canada, issued a joint warning with Novartis that Canadian physicians should frequently test patients for signs of atherosclerosis if they’re taking Tasigna. No such warning was made to U.S. physicians, leaving many patients at risk for severe complications.
Help from Hensley Legal Group
If you or a loved one has taken Tasigna and experienced a vascular adverse event, you may be entitled to compensation. Those who have taken Tasigna and suffered from circulatory issues, atherosclerosis, PAD, or amputation may have a valid claim against Novartis.
Hensley Legal Group is here to help those who have suffered from taking Tasigna. For more information, call our office today or contact us online for a free conversation about your potential claim.
DISCLAIMER: Please consult with your doctor before making any changes to your use of any FDA-approved drug or device.