Have You Experienced Harmful Side Effects From the Medication Xarelto?
In June 2014, the first lawsuits were filed in the United States over Xarelto’s side effects. Other lawsuits have since been filed, with many alleging that the drug’s manufacturer failed to adequately warn consumers about Xarelto’s side effects.
Learn more about our results or schedule a free confidential review of your case by contacting our Xarelto lawyers today.
Background on Xarelto®
Xarelto® (rivaroxaban) is one of the newest blood thinners to come on the market, and doctors often prescribe it to prevent blood clots and lower the risk of stroke in their patients. Taking Xarelto, however,comes with an increased risk of a serious side effect: severe internal bleeding.
Xarelto® is an anticoagulant, or blood thinner, developed by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals.
The Food and Drug Administration first approved the oral medication in 2011 to prevent blood clots in patients who have recently undergone a knee or hip replacement surgery. It was subsequently approved to prevent blood clots and stroke in those suffering from atrial fibrillation, and to treat deep vein thrombosis and pulmonary embolism.
Blood clotting is an important process that prevents excessive bleeding when a blood vessel in the body is injured.
It can be dangerous for blood to otherwise clot internally because clots can block blood flow and lead to serious medical problems.
People who have atrial fibrillation, for instance, face an increased risk of having blood pools in the chambers of the heart, which can then travel to the brain and cause a stroke.
Taking a blood thinner is often necessary for those patients to ensure the blood that collects in the heard does not clot.
On June 6, 2013, the FDA issued a letter regarding false and misleading claims by Xarelto in it’s advertising, because of the manufacturers’ marketing of Xarelto as a “one a day pill,” with “no regular monitoring.” The FDA considered this “false or misleading because it minimizes the risks associated with Xarelto and makes a misleading claim.”
- Fact: Xarelto’s Ads are False and Misleading
- Fact: Xarelto’s Ads Minimize the Risks
- Fact: Xarelto’s Ads Include Misleading Claims
If you think you have be at risk due to these misleading advertisements, contact Jacobs & Crumplar today for a free, confidential consultation with our Xarelto lawyers.
Xarelto Health Concerns
Xarelto has been marketed as a more convenient alternative to warfarin, a decades old generic drug that requires patients to undergo frequent blood tests and adhere to a strict diet. Warfarin is more commonly known by one of its brand names, Coumadin.
Unlike warfarin, however, Xarelto has no approved antidote or counteractive agent to stop any uncontrolled bleeding it may cause, according to a study in the journal Clinical Cardiology. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, it could cause the organ to lose some or all of its functionality. For that reason, uncontrolled hemorrhaging can be fatal, leaving Xarelto users vulnerable to organ damage and death.
Many of the Xarelto lawsuits that have already been filed claim that both manufacturers did not warn users that the drug could result in irreversible internal bleeding, which is especially important since there is no known reversal agent.
Kentucky resident Virginia Stunteneck filed a lawsuit in the U.S. District Court of the Eastern District of Pennsylvania against the makers of Xarelto after being hospitalized in 2013 with severe gastrointestinal bleeding following use of the drug. Stunteneck argued that the risks of uncontrolled bleeding should have been communicated on the drug’s packaging and, because there is no antidote, the drug should never have been sold.
“As the manufacturers and distributors of Xarelto, defendants knew or should have known that Xarelto use was associated with irreversible bleeds,” the complaint said. Others have also previously raised concerns about the way Xarelto is advertised.
A June 2013 letter sent from the FDA’s Office of Prescription Drug Promotion to the director of Johnson & Johnson explained that Xarelto’s print advertisement in the January/February 2013 issue of WebMD magazine was false or misleading because it minimized the risks associated with the drug and made a misleading claim.
The ad stated a variety of efficacy claims for Xarelto that were printed in “large, bolded and/or colorful text and graphics” to draw the reader’s attention, according to the letter. Some of the bolded phrases include “no routine monitoring,” “no dosage adjustments,” and “just one pill a day, taken with your evening meal.” Conversely, the risk information was printed without any of the emphasis used for the efficacy statements.
“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,” the letter said.
Kentucky resident Virginia Stunteneck filed a lawsuit after being hospitalized in 2013 with severe gastrointestinal bleeding following use of the drug. Stunteneck argued that the risks of uncontrolled bleeding should have been communicated on the drug’s packaging and, because there is no antidote, the drug should never have been sold.
- Fact: Xarelto Increases Risk of Severe Internal Bleeding
- Xarelto Has No Approved Antidote or Counteractive Agent to Stop Any Uncontrolled Bleeding
- Fact: Hemorrhaging Can be Fatal
If you think you have been at risk due to these misleading advertisements, call Jacobs & Crumplar today at (302) 656-5445 or contact us online for a free, confidential consultation with our Wilmington Xarelto lawyers.