A man has recently filed a lawsuit within the Xarelto multidistrict litigation alleging personal injury occurred from the product’s use.

Plaintiff Fred A. has filed a lawsuit because of a Xarelto gastrointestinal bleed and severe anemia that resulted in his need for multiple blood transfusions.

Xarelto is one of the “new” anticoagulants, also known as blood thinners. Generically known as rivroxaban, Xarelto has been heavily promoted by celebrities.

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 patients died as a result.

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.

Xarelto brought in $582 million in global sales in its first full year of being on the market.

Janssen received 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.

Xarelto Gastrointestinal Bleed Lawsuit

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 maintain the right dosage.

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.

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 gastrointestinal bleed or other internal bleed injuries.

The Institute for Safe Medication Practices noted in 2012 that during the FDA’s review process of Xarelto, “reviewers questioned the convenient once-a-day dosing scheme” of Xarelto because blood level studies had 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.”

Currently, there is no antidote for Xarelto. If a person is bleeding uncontrollably from Xarelto, there is no way to stop it.

In the Xarelto gastrointestinal bleed lawsuit, the makers and marketers of Xarelto are accused of using study results that “were flawed in design and conducted in a negligent manner” to make the drug appear safer and more effective than it actually is in their study known as RECORD 4.

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.”

The lawsuit says “As a result, the FDA found that the RECORD 4 studies were so flawed that they were deemed unreliable.”

The Xarelto Gastrointestinal Bleed Lawsuit is filed within MDL No. 2592, in the United States District Court for the Eastern District of Louisiana.