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Xarelto Issues

By Andrew Sullo

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What is Xarelto?

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 blood clots.

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.

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