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15 June 2015

Did the Drug Manufacturer Downplay Xarelto Side Effects?

xarelto side effects

Xarelto (Rivaroxaban) is a blood thinner drug that’s implicated in hundreds of lawsuits. Xarelto’s manufacturer, Janssen Pharmaceuticals and its parent company, Johnson & Johnson, has been under the microscope in recent months, as more and more court proceedings move forward in the many Xarelto lawsuits that have been filed.

Of course, these personal injury and wrongful death lawsuits have thrust the anti-coagulant drug’s manufacturer’s actions into the spotlight, leaving many to criticize the drug maker for its marketing, drug trials, Xarelto commercials and marketing material, study publications and more.

Xarelto Dosing and Indications

As a so-called “new generation” blood thinner, Xarelto is prescribed to patients with a range of different ailments and conditions. Xarelto indications include a propensity for forming blood clots and susceptibility to stroke. It’s prescribed for conditions like atrial fibrillation, pulmonary embolism and deep-vein thrombosis.

Xarelto dosing is much simpler compared to other anti-coagulant medications like coumadin/ warfarin, which requires frequent monitoring to ensure the drug maintains therapeutic levels. But in the Xarelto vs. coumadin analysis, there is one major flaw: coumadin has an antidote (vitamin K), whereas there is no Xarelto reversal agent.

Xarelto is not alone; another “new generation” anti-coagulant drug known as Pradaxa also lacks an antidote. But Pradaxa patients can undergo emergency dialysis to cleanse the drug from their system, effectively reversing its effects.

Unfortunately, this procedure is not effective for Xarelto. Physicians can only provide supportive measures until the drug naturally works its way out of the patient’s system. But the Xarelto half life — the amount of time it takes for the medication’s levels to drop to half of the original dosage — is 5 to 9 hours in a healthy, relatively young patient between the ages of 20 to 45; the Xarelto half life is even longer for those who are in less than perfect health, making treatment for uncontrolled bleeding even more complex.

Xarelto: Serious Side Effects

Xarelto is linked with a vast array of life threatening side effects including:

  • blood clot formation
  • subdural hemorrhage (bleeding in the area between the brain and the skull)
  • abdominal bleeding
  • low quantities of blood platelets and granulocytes
  • bile blockage and indigestion
  • intestinal bleeding
  • Stevens-Johnson Syndrome
  • hepatitis
  • rectal bleeding
  • urinary tract infections
  • hives, itching and anaphylactic shock
  • spinal epidural hematoma
  • renal/kidney bleeding
  • ….and beyond.

Xarelto Side Effects, Studies and Marketing

In 2014, Xarelto expended millions in advertising and sales totaled an estimated $1 billion. But many claim that the marketing and information provided to physicians and patients regarding this anti-coagulant medication has been skewed at best and deceptive at worst.

The makers of this medication have pointed to two Xarelto studies. One study, published in the New England Journal of Medicine in September 2011 examined Xarelto vs. warfarin as a drug for preventing stroke and treating atrial fibrillation, also known as “AF”. The study’s findings reportedly revealed that there was no major difference in the incidence of “clinically relevant non-major bleeding” incidents.

Another study examined Xarelto vs. enoxaparin sodium — another type of anti-coagulant medication — and the drugs’ effectiveness in treating pulmonary embolism. The study’s findings reportedly revealed that Xarelto had a “small superiority for major bleeding” when compared to the other blood thinner medication.

In a 2015 study comparing Xarelto vs coumadin, it was found that the “new generation” blood thinner had a 200% higher GI bleeding risk. Another new gen blood thinner, Praxaxa, also had a 50% higher risk of intestinal bleeding when compared to coumadin.

Yet critics point to the fact that both studies omitted any mention of a Xarelto reversal agent and the fact that there exists no Xarelto antidote. It’s omissions such as this that have left some to wonder whether the blood thinner medication’s manufacturers were intentionally deceptive in the materials they released, which also lack warnings of important facts — such as the fact that Xarelto reversal is not possible, even with dialysis.

Legal Representation for Xarelto Lawsuits

In 2013, over 2,000 serious Xarelto side effects and bleeding incidents were reported and more than 150 individuals have passed away as a result of the blood thinner’s side effects and/or from Xarelto complications.

The Meldofsky Law Firm currently represents a number of clients who’ve experienced serious blood thinner side effects and those who have lost a loved one due to uncontrolled bleeding from Xarelto complications. Xarelto lawsuits have already been filed by the hundreds; so many have been filed that they’ve been compiled into a multi-district litigation case.

If you or a family member has experienced serious Xarelto side effects or death from bleeding, contact The Meldofsky Law Firm to speak with us concerning your case in a free, confidential consultation. Simply call 877-274-8672.

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