FDA mini-sentinel assessment confirms safety and effectiveness of Xarelto (rivaroxaban) amidst lawsuit


The Janssen Pharmaceutical Companies of Johnson & Johnson has announced findings from the US Food and Drug Administration’s (FDA) mini-sentinel assessment, confirming the positive safety and efficacy profile of Xarelto (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety.

The announcement comes at a time of a lawsuit controversy, as thousands of Xarelto bleeding lawsuits will convene a hearing on January 30, 2018 to address the future of the massive litigation.

Building on the real-world evidence studied in over 200,000 people, the FDA’s recent findings are consistent with conclusions from other analyses and again confirm the drug’s safety and effectiveness across a wide range of patients. The FDA mini-sentinel report also notes a lower risk of ischaemic stroke was associated with the use of the  anticoagulant compared to vitamin K antagonist drug warfarin, lasting throughout the more than three-year analysis.

Xarelto is a direct oral anticoagulant that was initially approved by the FDA in October 2011. It is indicated for the treatment of patients suffering from deep vein thrombosis and pulmonary embolism as well as the prevention of deep vein thrombosis in people undergoing hip or knee implant surgery. It is also currently indicated for stroke prevention in patients with atrial fibrillation.

Xarelto producers battling lawsuits

Bayer and Johnson & Johnson have been named defendants in more than 20,000 drug lawsuits now pending in state and federal courts around the USA. All of these claims were filed on behalf of patients who allegedly suffered gastrointestinal haemorrhage, cerebral haemorrhage, haemorrhagic strokes and other episodes of life-threatening internal bleeding due to its use.

Among other things, plaintiffs allege that the Bayer and Johnson & Johnson downplayed the drug’s risks and wrongly marketed it as an improvement over a decades-old blood thinner called warfarin. The lawsuits point out that warfarin-related bleeding can be stopped via the administration of vitamin K. However, there is currently no approved antidote to reverse Xarelto bleeding side effects.

More than 19,000 lawsuits against the drug have been filed in the federal multidistrict litigation underway in the Eastern District of Louisiana. The proceeding convened three bellwether trials in 2017, all of which concluded with defense verdicts.

Last month, however, a jury in the Philadelphia Court of Common Please awarded US$28 million, including US$1.8 million in actual damages and US$26 million in punitive damages, to a woman who suffered a severe gastrointestinal bleed a little over a year after she was prescribed Xarelto.

Safety and efficacy reconfirmed by FDA


The recent FDA analysis evaluated the safety of the anticoagulant in people with nonvalvular atrial fibrillation who initiated Xarelto or warfarin from November 2011 to April 2015. To examine the safety of both products, methodologies included assessing ICD-9-CM codes from inpatient claims and evaluating rates of gastrointestinal bleeding, ischaemic stroke and intracranial haemorrhage in patients with atrial fibrillation.

In its report, FDA concludes, the study demonstrates the capability of FDA’s sentinel assessments “to conduct prospective safety monitoring with sophisticated re-usable tools, and does not raise any new safety concerns regarding use of Xarelto (rivaroxaban).”


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