What is Xarelto (rivaroxaban)?
Xarelto is an anticoagulant, taken orally that was approved to reduce the risk of stroke and systemic embolism [blood clots, DVTs, Pulmonary Embolus ] in patients with nonvalvular atrial fibrillation. Xarelto is also prescribed to prevent the recurrence of blood clots in the legs [DVT] or lungs [PE].
Xarelto [Rivaroxaban] is an oxazolidinone derivative optimized for inhibiting both free Factor Xa and Factor Xa bound in the prothrombinase complex. It is a highly selective direct Factor Xa inhibitor with oral bioavailability and rapid onset of action. Inhibition of Factor Xa interrupts the intrinsic and extrinsic pathway of the blood coagulation cascade, inhibiting both thrombin formation and development of thrombi.
Xarelto is manufactured and marketed by Johnson & Johnson International, Inc. (J & J) and Janssen Pharmaceuticals, Inc.
Xarelto is marketed as a “once a day”, “no blood tests or routine physician follow up necessary” and “no dose adjustments are needed” type of anticoagulant — very different from Heparin or Warfarin[Coumadin] which require frequent blood tests and Doctor visits to monitor platelet and clotting factors.
Janssen and J&J applied for an initial NDA for Xarelto® in July of 2008. Xarelto® was approved by the Food and Drug Administration (“FDA”) on July 1, 2011 to reduce the risk of blood clots, DVT, and PE following knee and hip replacement surgery. On November 4, 2011 Xarelto® was approved as an anti-coagulant primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. On November 2, 2012 the FDA expanded the use of Xarelto® to the treatment of patients with DVT and PE, as well as long-term treatment to prevent recurrence of the same.
In 2011, the U.S. Food and Drug Administration (FDA) first approved Xarelto (Rivaroxoaban), indicated to reduce the risk of strokes, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and blood clots in patients who have undergone hip or knee replacement surgery. Despite at least three attempts, it has not been approved to reduce blood clots in patients with coronary artery disease.
FDA WARNING LETTER
In June 2013 the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) reviewed Johnson & Johnson International, Inc. (J&J) direct-to-consumer (DTC) print advertisement for XARELTO (rivaroxaban) tablets (Xarelto) in the January/February 2013 issue of WebMD magazine. This is a medical journal read by both healthcare providers and patients.
The FDA told J&J/Janssen that their Print Ad is false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim. Thus, the Print Ad misbrands Xarelto in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(n) and FDA implementing regulations. 21 CFR 202.1(e)(5)(i); (e)(7)(viii), (ix).
Some of the companies claims include:
- “XARELTO® is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke—without routine blood monitoring.”
- “…With XARELTO®, there’s no routine blood monitoring—so you have more time for yourself. There are no dietary restrictions, so you’re free to enjoy the healthy foods you love. And there are no dosage adjustments, which means you can manage your risk with just one pill a day, taken with your evening meal. Learn how XARELTO® can help simplify your AFib-related stroke risk treatment….”
- The FDA criticized the above and notified the companies that :
- “In contrast, the risk information is presented on the preceding adjacent page without any of the emphasis (i.e. color scheme, borders, layout, and graphics) used with the efficacy claims. The result is a presentation which appears unconnected to the efficacy claims and is therefore not likely to draw readers’ attention. This overall presentation misleadingly minimizes the risks associated with Xarelto because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims.”
Misleading Claims noted by the FDA:
- “The Print Ad includes the following claim (emphasis original):
- “And there are no dosage adjustments…”
- “The above claim misleadingly suggests that dosage adjustments are not necessary with Xarelto. However, according to the DOSAGE AND ADMINISTRATION section of the PI[Product Insert], the dose should be lowered to 15 mg once daily for patients with renal impairment who may have a Creatine clearance of 15 to 50 mL/min. In addition, the WARNINGS AND PRECAUTIONS section of the PI states, “…Periodically assess renal function as clinically indicated…and adjust therapy accordingly….” Thus, patients with renal impairment may need to have their dosage adjusted while on Xarelto therapy. “
The FDA noted that the most common adverse reactions with Xarelto were bleeding complications.
FAILURE TO WARN
The manufacturers boxed warning did not address the increased risk for serious and fatal bleeding, despite the fact that the information listed on their website originating from the Rocket AF clinical trial sponsored by the manufacturers, states that in comparison to warfarin, patients taking Xarelto® have more gastrointestinal bleeds and need more transfusions. In spite of this reference regarding bleeds, the information is still wholly inadequate because, this information was not conveyed in the boxed warning on the Xarelto® label.[i]
Due to the defective nature of Xarelto®, persons who were prescribed and ingested Xarelto®, for even a brief period of time, were at increased risk for developing life-threatening bleeds. Therefore, the flawed formulation of Xarelto®, which according to J&J/Janssen does not require regular blood monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, bleeding, and blood clots if not taken properly or absorbed properly, particularly in patients with poor renal function. In addition, “[p]rominent U.S. [cardiologists and health care professionals] stress that neither new drug [Xarelto] has a known antidote for a bleeding emergency, as warfarin does.”[ii]
FDA clinical reviewers have stated that “rivaroxaban should not be approved unless the manufacturer conducts further studies to support the efficacy and safety of rivaroxaban” and the FDA website notes that “[a]dverse event reports of thrombocytopenia and venous thromboembolic events were identified” in relationship to Xarelto®”.[iii] However, this information was not portrayed in the warning section on the warning label. The lack of efficacy of the medication for patients taking Xarelto® post hip and knee surgery were not disclosed resulting in patients ingesting Xarelto® and physicians prescribing Xarelto® without sufficient information to make an accurate decision.
MARKETING & OVERPROMOTION
J&J/Janssen routinely marketed Xarelto® as a “one size fits all” drug. In their fervent marketing of Xarelto, these companies misinformed patients and their healthcare providers as to the necessity to routinely monitor any patient requiring a blood thinning agent. In essence, they have created a new drug, Xarelto®, that is not better than warfarin from a safety perspective, and at best, is only perhaps slightly easier to use and administer. The idea of this apparently easier-to-use anticoagulant evidently appealed to physicians, who were subject to extreme marketing and promotion by these companies, but ignores patient safety.
As a result of Defendants’ intense marketing, “[a]bout 130,000 U.S. prescriptions were written for Xarelto® in the first three months of 2012” resulting in large profits as Xarelto® costs approximately $3,000 a year versus $200 for generic warfarin.[iv]
As a result of J&J/Janssen’s extreme marketing tactics, within the United Kingdom, they increased their sales to 219 million Euros from Xarelto®, more than three times as much as during the same period last year.
REPORTED ADVERSE EVENTS
According to Institute for Safe Medication Practices, QuarterWatch Report, issued on October 3, 2012, the primary reported adverse event related to Xarelto® use “was not the well- understood risk of hemorrhage. Instead, the largest identifiable category was serious blood-clot- related injury–most frequently pulmonary embolism–the very events rivaroxaban is intended to prevent.” This lack of efficacy for short term users of Xarelto® post hip and knee replacement surgery resulted in about 44% of the reported adverse effects from taking Xarelto®.
Serious and Life-threatening Side Effects of Xarelto, include:
- Vaginal hemorrhage with excessive bleeding during periods causing anemia & requiring blood transfusions;
- Uncontrolled bleeding
- Gastrointestinal Hemorrhage with Hematomas
- Hemoglobin Decrease with anemia
- Cerebrovascular Accidents
Symptoms of Xarelto bleeding side effects may include:
- Unusual bruising or bleeding
- Pink or brown urine
- Red or black tarry stools
- Coughing up blood
- Vomiting that resembles blood or looks like coffee grounds Headaches
- Bleeding from the gums
- Frequent nose bleeds
- Vaginal hemorrhage with excessive bleeding during periods causing anemia & requiring blood transfusions;
- Weakness and swelling in the hands, arms, lower legs, ankles or feet Joint pain or swelling
Failure to warn patients of side effects of Xarelto i.e. uncontrollable internal bleeding side effects.
Failure to warn patients that the uncontrollable internal bleeding caused by Xarelto could not be reversed as easily as with other anticoagulants.
Improper monitoring instructions causing increased number of DVTs, PEs which it is supposed to prevent.
How Experienced Nationwide Attorney and Former Nurse Liz Dudley’s National Litigation Practice Can Help You
If you or a loved one has experienced severe bleeding, hemorrhage from the use of Xarelto and the bleeding/clotting episodes have caused you to be admitted to the hospital and have been documented by a healthcare provider we encourage you to immediately protect your rights and to seek compensation for injuries sustained. Nurse-Attorney Dudley is experienced and knowledgeable in the field of pharmaceutical and personal injury litigation, represents clients nationwide in a variety of pharmaceutical and device litigations and assists her clients in finding medical experts who can help them recover from the injuries caused by defective drugs and devices. Nurse-attorney Elizabeth Dudley, who is centrally located in Kansas, can help you navigate through your claim against these companies. To schedule your complimentary case review, please contact our law office or fill out the contact form to your right.
DISCLAIMER: Before stopping any medication you must first consult with your physician. Suddenly stopping a drug like Xarelto may lead to a wide variety of complications. If you want to stop taking Xarelto, please consult with your prescribing physician . This webpage is designed to provide information about potential and ongoing litigation against the manufacturer of Xarelto and is not providing any medical advice.
Frank Siebelt, Hans Seidenstuecker, and Christoph Steitz. “Reports of side-effects from Bayer’s Xarelto grow: Spiegel” http://www.reuters.com/article/2013/09/08/us-bayer-xarelto-idUSBRE9870AH20130908