Xarelto is a blood thinner medication, similar to Pradaxa and Coumadin (warfarin), used to reduce the risk of blood clots and strokes in patients with atrial fibrillation (irregular heart rhythms) not caused by heart valve problems. But Xarelto users have reported serious side effects, including internal bleeding and hemorrhaging for which there is no antidote.
What is Xarelto?
Xarelto, is one of the newest blood-thinners on the market, generically known as rivaroxaban. According to the manufacturers, it helps patients with atrial fibrillation lower their chances of having a stroke by preventing blood clots from forming. The prescription anticoagulant is marketed to generally reduce blood clots from forming in veins within the body (deep vein thrombosis), the lungs (pulmonary embolism) and in patients who undergo knee or hip replacement surgery. Xarelto is manufactured by Bayer and marketed in the U.S. by Janssen Pharmaceutica, a division of Johnson & Johnson.
Importantly, there is no antidote to Xarelto, unlike Coumadin (warfarin). Xarelto is one of the new generation of blood thinners which includes other coagulants such as Praxdaxa (dabigatran) or Eliquis (apixaban) that claim to be safer and more effective than the Coumadin (warfarin). However, as discussed in an abstract by the U.S. National Institutes of Health, there is no antidote nor is there any specific treatment that has been proven effective for handling severe bleeding caused by these anti-clotting drugs.
Xarelto’s Dangerous Side Effects
The most commonly reported side effects of the blood thinner are uncontrolled bleeding, and severe internal bleeding. Other known complications include:
- Red, pink, or brown urine
- Bright red or black stools
- Vomiting blood or vomit that looks like “coffee grounds”
- Unexpected or long-term bleeding
Pain, swelling, or new drainage at wound sites.When the FDA approved Xarelto in November 2011, it issued its most serious warning, called a “black box warning” which cautioned Xarelto users who suddenly stop taking Xarelto are at an increased risk for stroke if the medication is not replaced by another blood thinner to prevent a blood clot from developing. The FDA required additional warnings that epidural or spinal hematomas have occurred in Xarelto users who were receiving anesthesia or undergoing spinal puncture. The hematomas could result in long-term or permanent paralysis.
Therefore, in the event of internal bleedings and hemorrhagic complications, there is no available antidote or reversal agent. The original U.S. label approved when the drug was first marketed in the U.S. did not contain a warning regarding the lack of antidote, but instead only mentioned this important fact in the overdosage section.
Studies on Xarelto Says Bleeding More Frequent
Xarelto was examined in a clinical study published in the September 2011 issue of the New England Journal of Medicine. The double-blind trial, called ROCKET AF, used 14,264 patients with atrial fibrillation who were at increased risk of stroke. The patients were assigned to take either Xarelto or Warfarin blood thinners. The research found that Xarelto was shown to be “noninferior” or just as effective for preventing stroke or blood clots as Warfarin. However, the study also mentioned “bleeding from gastrointestinal sites, including upper, lower, and rectal sites, occurred more frequently in the rivaroxaban [Xarelto] group, as did bleeding that led to a drop in the hemoglobin level or bleeding that required transfusion.”
Even though this study was publicized before Xarelto hit the market, the makers of the drug did not warn Doctors or the public about the increase risk of internal bleeding.
Filing A Xarelto Lawsuit
If you or someone you love suffered Xarelto’s serious side effects, such as severe bleeding, internal bleeding, blood clots, stroke, or heart attack from taking Xarelto, you may be eligible to file lawsuit against the manufacturer of the blood thinner.
Written by:
Paige Boldt
Watts Guerra LLP
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San Antonio, Texas 78257
Phone (210) 447-0500
© Watts Guerra LLP 2015
