More than 7 million people worldwide have been prescribed Xarelto, and at least 2 million Americans have atrial fibrillation that’s treated with Xarelto. If you or a loved one was prescribed and took Xarelto you may be entitled to compensation.
Xarelto was designed to replace an older drug called warfarin (Coumadin). Warfarin still in use today. It was originally approved in 1954 by the FDA, it can easily be reversed with Vitamin K, the blood element that causes clotting.
Warfarin requires the doctor who prescribed it to monitor a patient’s diet and dosage carefully. Xarelto, on the other hand, was marketed as a once-a-day dose, despite that it has a short half life: between 5-9 hours.
There was a strong profit motive to create a new drug when warfarin became generic. The lowest available price of 30 standard warfarin tablets is $4. The lowest price for 30, 5 mg Xarelto tablets? — $405.
In 2014, Johnson & Johnson had sales totaling $3.7 billion for Xarelto alone.
Xarelto has no reversal agent
The FDA approved Xarelto as a once-a-day blood thinner to reduce the risk of blood clots after hip or knee replacement surgery in July 2011. A few months later in November 2011, it was approved to reduce the risk of stroke from atrial fibrillation. Then in November 2012, the agency expanded it to treat deep vein thrombosis and pulmonary embolism.
Since Xarelto went on the market, the manufacturers ignored the dangers of Xarelto. It has no reversal agent or antidote, and can cause uncontrollable internal bleeding. Also, its alleged that Xarelto can actually cause strokes and blood clots if discontinued abruptly. Moreover, makers of the drug failed to warn users and actually concealed the fact that Xarelto causes uncontrolled internal bleeding.
Companies Ignored Danger Signals About Xarelto
Studies began showing as early as 2008 that Xarelto was more dangerous than other blood-thinning drugs. The New England Journal of Medicine published articles in 2008, 2011 and 2012 all of which discussed an increased risk of adverse events.
In 2012, the FDA recorded “serious adverse events” reports about Xarelto. This was the first year after the drug was on the market and there were 2,081 serious adverse events. 151 of those were deaths, compared to only 56 deaths from warfarin.
In 2013 and 2014, the FDA required that Xarelto drugmakers include boxed warnings.
• In 2013, the FDA required that Xarelto include a warning that premature discontinuation of Xarelto® increases the risk blood clots.
• In 2014, the FDA required that Xarelto include a warning that it can cause internal bleeding. The warning must also state that a specific antidote is not available for Xarelto.
If you or someone you know has suffered damages as a result of taking Xarelto, including but not limited to internal bleeding, stroke, blood clots or death, contact Jorge P. Gutierrez Jr. of The Gutierrez Firm for a free consultation.