Xarelto (Rivaroxaban) is one of the newer anticoagulant drugs, more commonly known as blood
thinners. Doctors prescribe blood thinners as a means of preventing dangerous blood clots.
Older anticoagulants, such as Warfarin, must be prescribed in a specific dosage, tailored to the
individual. The patient must also undergo regular, monthly blood testing while on Warfarin as
well as avoiding certain foods which contain vitamin K. Xarelto is prescribed in one uniform
dosage, making it easier for the doctor to prescribe, and generally easier for the patient to take as
there are currently no known food interactions and no required blood testing.
On the flip side, there may be more adverse, potentially serious Xarelto issues than for patients
taking Warfarin—which was approved in 1954, therefore has over sixty years’ worth of history
behind it. Rivaroxaban, like other anticoagulants, reduces the ability of the blood to clot, thereby
preventing harmful blood clots from forming in the blood vessels. Often, Xarelto is used for
patients undergoing hip or knee replacement surgery to prevent potential blood clots and to treat
blood clots in those who have previously had a deep vein thrombosis (particularly in the leg),
or a pulmonary embolism. There may be certain other conditions for which your doctor would
prescribe Xarelto, such as for atrial fibrillation.
Who Manufacturers Xarelto?
Bayer and Johnson & Johnson’s New Jersey-based unit, Janssen Pharmaceuticals, work together
in a joint development, marketing and manufacturing Xarelto. Bayer’s pharmaceutical branch
is based in Germany, and had net sales in 2013 $1.3 billion; Bayer manufactures cardiovascular
medicines, women’s healthcare products and hormone replacement therapies in addition to
Xarelto, as well as certain drugs to treat cancer. In the pharmaceuticals market, Bayer is among
the top fifteen companies, in terms of sales.
Bayer distributes pharmaceutical products through wholesalers, pharmacies and hospitals,
as well as co-promotions and co-marketing agreements such as the one with Janssen
Pharmaceuticals. Janssen Pharmaceuticals is a division of Johnson & Johnson, providing
prescription drugs for ADHD, mental health, pain management, women’s health, and general
medicine. Janssen is headquartered in Titusville, New Jersey.
How Does Xarelto Work?
Xarelto is a selective inhibitor of Factor Xa, and does not require a cofactor, such as Anti-
thrombin III for the drug to work. Rivaroxaban, in the form of Xarelto, inhibits prothrombinase
activity, but has no direct effect on the aggregation of platelets. Xarelto acts quickly, with no
dosage modifications according to age, weight or gender of the patient, although the dosage is
adjusted according to the medical issue being treated. In general, 15 mg of Rivaroxaban is used
to reduce the risk of stroke, or for DVT and PE treatment. To reduce the risk of recurrence of
DVT and PE, 20 mg. per day is the usual prescription, with 10 mg of Xarelto per day prescribed
following knee or hip replacement surgery. Xarelto reaches maximum inhibition of Factor XA
activity between two and four hours following ingestion.
FDA Approval for Xarelto
Bayer initially submitted Rivaroxaban for approval in the United States to be used in the
prevention of venous blood clots following knee or hip surgery in 2008. In March, 2009, an FDA
advisory committee found a favorable risk-benefit profile for Rivaroxaban used for venous blood
clot prevention, and in July, 2009, the FDA approved Bayer’s application for Rivaroxaban in the
United States. In January, 2011, an application was submitted to the FDA for Rivaroxaban for
use in stroke prevention and atrial fibrillation; this application was approved in July, 2011. In
November, 2012, the FDA expanded the use of Rivaroxaban to treat and reduce the recurrence of
Potential Problems with Xarelto
Growing complaints of potential risks and even deaths tied to Xarelto have made cardiologists
hesitant to prescribe the drug, and some physicians believe a more rigorous monitoring regimen
is warranted when Rivaroxaban is prescribed. One of the primary issues associated with Xarelto
is that the drug does not have a known antidote for a bleeding emergency, while the older drug,
Warfarin, does. Cost may be an issue as well; Xarelto can cost as much as $3,000 per year,
versus $200 per year for generic Warfarin.
Some believe Bayer and Janssen Pharmaceuticals may not have adequately warned consumers
about the potential risks associated with Xarelto. Possible risks of Rivaroxaban include nose
bleeds, bleeding into the brain and spine, gastrointestinal bleeding, bleeding from the genitals,
eyes, skin, joints or muscles, wound bleeding following a procedure, and/or blood in the urine.
Kidney problems, skin rashes, extremity pain, tiredness or weakness and nausea and vomiting
are have also been seen in those taking Rivaroxaban. Less common potential issues include
serious allergic reactions, fainting or brief loss of consciousness, a general unwell feeling or liver
problems. Rare (less than one in 10,000) but possible adverse reactions to Rivaroxaban include
angina, breathing difficulties, chest pain, circulation problems, jaundice and shock. Since the
release of Xarelto, numerous adverse reaction reports have been filed with the FDA.
If you have taken Rivaroxaban and experienced serious Xarelto issues, it is important to first
look after your health, then to speak to an experienced Xarelto lawyer to determine whether you
have a valid case against the manufacturer of the drug.