SproutNews logo

A Look At Black Box Warnings As Xarelto Lawsuit Numbers Grow

March 25, 2016 – – BloodThinnerHelp.com reports on the black box warnings issued for Xarelto by the FDA. The drug, manufactured by Johnson & Johnson and Bayer AG, has been issued two black box warnings since its debut to the U.S. market in 2011.

A black box warning is described by the FDA as a type of warning that “appears on a prescription drug’s label and is designed to call attention to serious or life threatening risks.” It is considered the strictest warning the FDA can give in regard to a drug’s safety. Xarelto’s black box warnings include one stating that patients who prematurely discontinued Xarelto were at a higher risk of blood clots, deep vein thrombosis, and epidural/spinal hematoma. Another notes “optimal timing between the administration of XARELTO and neuraxial procedures is not known.” The warning elaborates to explain that “placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of rivaroxaban is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known.”

While these warnings have been issued by the FDA, many patients using Xarelto feel that the manufacturers downplayed the seriousness of the side effects mentioned in the warning. Thousands of plaintiffs have now come forward alleging that they suffered serious side effects as a direct result of the drug. Side effects plaintiffs have claimed to suffer include internal bleeding, gastrointestinal bleeding, rectal bleeding, brain hemorrhaging, pulmonary embolism, stroke, heart attack and epidural hematoma.

Federally-filed cases have now reached close to 3,000 in number and have been consolidated through the creation of a multidistrict litigation panel in Eastern Louisiana for more efficient management. Those cases filed in the commonwealth of Pennsylvania have been added to a mass tort program that has reached 620 cases.

As those plaintiffs await trials, Attorney Joseph Osborne is working with those who believe they may have been negatively affected by the blood-thinning drug. He is working to ensure that those affected parties have the opportunity to thoroughly look into their legal rights. Qualifying individuals may be entitled to financial compensation and legal action. Osborne is currently offering complimentary legal consultations to those who believe they have been affected.

For more information, or to ask questions about Xarelto, contact Joseph Osborne, Esq. by calling (866) 425-8902.

###

Contact BloodThinnerHelp.com:

Joseph Osborne
866-425-8902
Mizner Park
433 Plaza Real Blvd., Ste. 271
Boca Raton, FL 33432

ReleaseID: 60008872

Go Top