Two recent studies have linked Xarelto, a blood-thinning drug manufactured
by Johnson & Johnson, to an increased risk of stomach bleeds and eye
hemorrhaging. In the first study, two doctors found a significant number
of patients in their 70’s and 80’s who switched from Warfarin
to Xarelto suffered a bleed between the lens of the eye and the retina.
These cases were reported in the June 2015 issue of JAMA Ophthalmology.
The second study, published in April 2015 in the British Medical Journal,
concluded a twofold higher risk of stomach bleeding with Xarelto as compared
to Warfarin could not be ruled out.
Xarelto Linked to Uncontrolled Bleeding Events in the Past
Xarelto has been linked to uncontrolled bleeding among those taking the
drug in the past. While these new side effects are serious, the primary
concern remains an uncontrolled bleed which could lead to death. Pradaxa,
a blood thinner which works in a similar manner as Xarelto, recently settled
more than 4,000 claims involving uncontrolled bleeds for approximately
$160,000 per case. Xarelto currently has more than 300 lawsuits pending
in federal litigation in Louisiana, and another 160 cases pending in Pennsylvania’s
mass tort proceeding.
Warfarin vs. Xarelto
A number of fatal and near-fatal bleeding incidents have occurred among
patients taking Xarelto. Coumadin and Warfarin, an older class of blood
thinners, have been prescribed for more than six decades, however patients
taking the drugs must be monitored regularly. Both drugs have certain
food and drug interactions, and the dosage is dependent on the patient’s
age, gender and weight. Xarelto, and similar drugs such as Pradaxa, are
prescribed in a standardized dosage, there is no blood monitoring required,
and there are no known food or drug interactions.
How is Xarelto Used?
Xarelto (Rivaroxaban) reduces the ability of the blood to clot, reducing
the risk of dangerous or fatal blood clots forming in the blood vessels.
Xarelto was first approved to use for patients undergoing hip or knee
replacement surgery in order to prevent blood clots or treat blood clots
in patients with a history of deep vein thrombosis or pulmonary embolism.
Xarelto is also prescribed for patients with atrial fibrillation. While
it may sound like Johnson & Johnson created a near-magical blood-thinning
drug, there are, unfortunately, some negative issues associated with the drug.
The Downside of Xarelto
When a patient taking Warfarin or Coumadin experiences an uncontrolled
bleed, the doctor can administer a shot of Vitamin K, which fairly quickly
reverses the effects of the drug. There is no such reversing agent for
Xarelto; when a patient is bleeding uncontrollably, doctors have no options
other than transfusing blood to the patient, hoping the bleeding will
stop on its own. This is particularly concerning among the elderly who
take Xarelto. Older patients, particularly when they live alone, could
have a dizzy spell, take a fall in their home, receive a relatively minor
wound, and bleed out before being found by anyone.
Deaths Associated With Xarelto
In 2012, fifty-eight deaths were tied to the use of Xarelto, and in 2013,
another seventy-two. While Xarelto currently contains two black box warnings,
neither is related to uncontrolled bleeding events. Patients taking Xarelto
have suffered rectal bleeding and brain hemorrhage, and this latest research
adds the risk of gastrointestinal bleeding and hemorrhaging from the eyes.
Despite three FDA rejections for the expanded uses of Xarelto, Johnson
& Johnson and its subsidiaries, Bayer and Janssen, continue to push
for additional approval, particularly to treat acute coronary syndrome
and clogging of heart stents.
While a number of studies—including these latest studies regarding
stomach bleeds and eye hemorrhaging—implicate Xarelto in potentially
fatal bleeding events, Johnson & Johnson continues to aggressively
push the drug. Although Xarelto has been on the market only since late
2011, sales of the drug topped $1 billion by the last quarter of 2014.
Even so, this new data comes at a tough time of J & J as they fight
an ever-increasing number of claims. It is expected the Xarelto litigation
will be lengthy and that more plaintiffs will come forward as time passes.
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
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national dangerous drug lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.