Kim Gale  |  February 24, 2017

Category: Legal News

Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

Xarelto GI bleeding problems blood thinnerXarelto GI bleeding problems rank high among the issues patients can face when taking this new anticoagulant, also known as a blood thinner.

Janssen Pharmaceuticals received FDA approval for Xarelto in July 2011 for the prevention of deep vein thrombosis and pulmonary emboli in patients undergoing hip replacement or knee replacement surgeries.

Generically known as rivroxaban, Xarelto has been heavily promoted by celebrities in print and on television.

The drug’s marketing department spent more than $11 million in 2013 promoting the drug. In the third quarter of the 2013 fiscal year, Xarelto was the number one pharmaceutical item promoted in professional health journals based on pages and dollars spent.

These marketing efforts appear to have paid off. Xarelto brought in $582 million in global sales in its first full year of being on the market.

Yet Xarelto bleeding injuries and failure to prevent a stroke or pulmonary embolism topped the list of adverse events submitted to the FDA last year, according to the Institute for Safe Medication Practices (ISMP). More than 1,100 patient deaths have been reported.

Xarelto GI Bleeding Problems

Xarelto has been marketed as a great alternative to Coumadin, generically known as warfarin, which has been around for about 50 years.

When on warfarin, a patient needs to take INR (international normalized ration) blood tests to determine how fast the blood clots. This test helps patients maintain the right dosage of warfarin.

If for some reason a patient needs to have warfarin’s anticoagulant properties cease due to accident or injury, a number of options for reversal are available, including vitamin K.

But currently, there is no antidote for Xarelto. If a person is experiences Xarelto GI bleeding problems, there is no medication available that can slow or stop it.

One of Xarelto’s biggest selling points is that it does not need any testing in order to ensure a therapeutic level is maintained and that it is a once daily dose. However, patients tolerate Xarelto differently, which means some patients are more prone to Xarelto GI bleeding problems or other internal bleed injuries.

The ISMP noted in 2012 that during the FDA’s review process of Xarelto, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto. Blood level studies suggested that “twice daily dosing, which would produce lower peak blood levels and higher trough blood levels of (Xarelto), might have been associated with greater efficacy and/or a better safety profile.”

Clinical studies used to support FDA approval for Xarelto have also been called into question. In 2009, the FDA Official Action Indicated (OAI)-rated inspections listed violations in Xarelto’s RECORD 4 study, including “systemic discarding of medical records,” unauthorized unblinding, falsification and “concerns regarding improprieties in randomization.”

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The Xarelto attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or Xarelto class action lawsuit is best for you. [In general, Xarelto lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

Learn More

Get Help – It’s Free

Join a Free Xarelto Class Action Lawsuit Investigation

If you or a loved one took Xarelto (rivaroxaban) and suffered injuries such as uncontrollable internal bleeding, gastrointestinal bleeding, hemorrhaging, deep vein thrombosis or pulmonary embolism, you may have a legal claim. See if you qualify by filling out the short form below.

An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

Please Note: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client, if you qualify, or getting you dropped as a client.

Oops! We could not locate your form.

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.