SILVER SPRING, Md. — Because of the ease with which it can be prescribed, Xarelto (rivaroxaban) has become a popular alternative to other blood thinners such as Coumadin (warfarin), which requires more doctors visits and tests. However, unlike Coumadin (which can be counteracted with Vitamin K), Xarelto users are left prone to serious internal bleeding if they receive too high of a dose of the drug.
Although prothrombin complex concentrate (PCC) has been known to slightly reverse the effects of Xarelto, there is currently no effective antidote for the blood thinner that has been approved by the United States Food and Drug Administration for this purpose. If a patient receives too much Xarelto for whatever reason, he or she will have to discontinue taking the drug and wait for its effects to stop, which can take a whole 24 hours.
Fortunately, there may be an antidote in sight thanks to Portola Pharmaceuticals and its new drug Andexanet alfa, which is in the promising late stages of the company’s internal testing. According to the results of a Phase 3 study by the drug makers, Andexanet alfa succeeded in “rapidly and significantly” reversing the blood-thinning effects of Xarelto. Andexanet alfa does need to be injected intravenously, but its effects begin to show within minutes, and the study shows that the antidote has resulted in a “near-complete reversal” of Xarelto’s anticoagulant effects. According to the study, the antidote resulted in no adverse side effects. Portola Pharmaceuticals plans to submit their drug by the end of 2015 for FDA approval.
The lack of an antidote to the internal bleeding that can result from the use of Xarelto has resulted in many lawsuits being filed against the drug’s manufacturers, Johnson & Johnson and Bayer AG. Many of the suits allege that Johnson & Johnson and Bayer marketed Xarelto by playing up its positive uses while downplaying its potentially fatal side effects, including severe bleeding. There are even dozens of cases that allege that Xarelto resulted in death from bleeding out. The use of Xarelto has also been linked to other serious side effects, including deep vein thrombosis, pulmonary embolism or strokes.
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