Though Xarelto has been shown to have devastating side effects causing injuries and even death, to date no Xarelto recall has been ordered by the U.S. Food and Drug Administration (FDA), which approved the blood-thinning drug in November of 2011. Nor has the defective drug’s manufacturer ordered a voluntary Xarelto recall.
But that hasn’t stopped Xarelto lawsuits from being filed by victims of the defective drug.
Also lacking are proper and sufficient Xarelto warnings for the dangerous drug’s possible side effects. In fact, the lack of a proper Xarelto warning for internal bleeding, strokes or blood clots can be part of the basis for a defective drug lawsuit.
With more such lawsuits, an Xarelto recall eventually could be made, either as ordered by the FDA or by the manufacturer.
Until that time, persons using Xarelto as an anticoagulant, or blood thinner, should be aware of preliminary Xarelto warnings issued by the FDA or made by physicians who have studied the drug and its Xarelto side effects.
To date the FDA has made an Xarelto warning that the drug possibly could cause bleeding — the very thing it’s designed to prevent. For its part, the FDA warns physicians prescribing Xarelto as a blood-thinner or anticoagulant to “promptly evaluate any signs or symptoms of blood loss and consider the need for blood replacement” (or transfusions).
The FDA also notes that “A specific antidote for rivaroxaban (Xarelto’s chief active ingredient) is not available.” As a result, if a person suffers uncontrolled internal bleeding due to defective blood-thinning drug Xarelto, the victim must have the drug flushed from their system via repeated blood transfusions.
Yet despite such FDA warnings, despite reports of injuries and deaths caused by Xarelto and despite Xarelto lawsuits being filed as a result, the drug continues to be sold without an Xarelto recall.
The basis for an Xarelto lawsuit can include the fact that its makers, Bayer and Johnson & Johnson, have failed to provide Xarelto warnings for the product, particularly in terms of its hemorrhaging side effects.
But more FDA warnings also are needed. That’s why victims have asked the FDA to provide a so-called “Black Box Warning” — the most stern warning it can place on a drug’s packaging — of Xarelto’s dangers.
Such Xarelto warnings could spare many people injury or death due to the defective drug.
If someone in your family suffered internal bleeding and was hospitalized after taking Xarelto, or suffered a blood clot or stroke after using the drug, let us know. Our law firm can fight for your legal rights by filing an Xarelto lawsuit on your behalf.
For now, all you need to do is notify us through our online case review form, or by calling us. Then we’ll offer you a free case review, and after that you can decide if you want to proceed with an Xarelto lawsuit.