Xarelto was approved by the FDA in 2009 for the prevention of blood clots
in those undergoing knee or hip surgery. In 2011, Xarelto gained approval
to treat those with atrial fibrillation and for stroke prevention in patients.
Xarelto has also been approved to treat and reduce recurring blood clots.
Johnson & Johnson, the maker of Xarelto, has spent millions of dollars
touting the benefits of Xarelto while denouncing the benefits of Warfarin
and Coumadin. Unfortunately, Xarelto has been tied to uncontrolled bleeding
events, which can lead to hospitalization, serious injury, and even death.
There are currently more than 400 Xarelto lawsuits filed under a federal
MDL, and more are expected in the coming months. If you have suffered
injury after being prescribed Xarelto, and are considering filing a lawsuit,
the following points could be useful:
- Xarelto inhibits the Xa direct factor which interferes with the normal
blood clotting abilities of the body. Some people experience an overabundance
of clotting including patients with atrial fibrillation, characterized
by blood pooling in the heart and clotting. Blood clots which develop
in the legs or the lungs can lead to serious complications if not treated promptly.
- The manufacturers of Xarelto are Bayer AG, Janssen and Johnson & Johnson.
More than seven million people across the globe have been prescribed Xarelto.
- Unlike older blood thinners such as Warfarin and Coumadin, there is no
known antidote to uncontrolled bleeding events triggered by Xarelto. If
a patient experiences uncontrolled bleeding while taking Warfarin or Coumadin,
Vitamin K can be administered, which will restore the body’s blood
clotting. Doctors can do nothing for patients taking Xarelto who experience
- Many doctors prescribe Xarelto rather than Warfarin because Xarelto does
not require frequent blood testing and, according to the manufacturers,
there are no known drug or food interactions.
- There are reports that another company has developed a reversal agent for
Xarelto and drugs like it, however there has been no approval of the agent.
- One Xarelto study found that more than 73% of the subjects in the study
developed at least one adverse side effect.
- In 2013, sales of Xarelto topped $1.4 billion, making the drug a resounding
financial success for Bayer, Janssen and J & J.
- Among the lawsuits currently filed, the injuries include gastrointestinal
bleeding, rectal and vaginal bleeding, brain hemorrhage, stroke, heart
attack, pulmonary embolism and epidural hematoma.
- Many of these lawsuits allege the manufacturers concealed important safety
information and failed to conduct adequate testing of Xarelto prior to
- There are two black box warnings on Xarelto; the first warns patients undergoing
spinal procedures or receiving spinal anesthesia of the risk of paralysis
and the second informs those with non-valvularatrial fibrillation that
when Xarelto is abruptly discontinued, an increased risk of blood clots
or stroke exists.
Xarelto Adverse Events
More than 1,800 adverse event reports have been associated with Xarelto
since its release, with the most frequent issues being gastrointestinal
bleeding, deep vein thrombosis, pulmonary embolisms and an increase in
hematomas. During the first eight months of 2013 alone, there were 72
reports of Xarelto deaths. Despite claims to the contrary, Xarelto has
been found to react adversely with anti-inflammatory medications, some
herbal remedies, antivirals and antibiotics.
A report from the Institute for Safe Medication Practices identified 356
reports of serious, disabling or fatal injury associated with Xarelto.
Patients who are taking Xarelto while undergoing spinal or epidural anesthesia
may potentially experience paralysis. While the FDA has not require uncontrolled
bleeding to be a black box warning on Xarelto, it is listed under the
adverse reactions section. Those who have experienced injury after taking
Xarelto should speak to an experienced Xarelto attorney to determine whether
they could be eligible for compensation.
Contact Our National Dangerous Drug Lawyers
If you have suffered medical complications, pain, or excessive bleeding
after using Xarelto, your injuries may be the result of a drug manufacturer's
negligence. To learn more about your legal options or to schedule a free
consultation call the Philadelphia class action lawyers at
Golomb & Honik today at
215-985-9177 or fill out our confidential