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Johnson & Johnson’s Janssen subsidiary has announced plans to release a low-dose version of its controversial anticoagulant Xarelto, designed for use against recurring blood clots. The move comes as the drug maker continues to faces thousands of ongoing Xarelto lawsuits, alleging that users suffered severe and uncontrollable bleeding problems following use of the drug.
In a press release issued on June 28, Janssen indicates that the FDA has granted priority review of a supplemental new drug application for low dose Xarelto, which would be marketed as a 10 mg once-daily version of the novel oral anticoagulant.
The drug maker claims that a study has shown Xarelto to be more effective than aspirin at preventing recurring venous thromboembolism (VTE), which is a serious clotting condition that can cause deep vein thrombosis and pulmonary embolism, both of which can be life threatening.
The priority review designation from the FDA means that the agency believes the low dose version could offer significant health benefits, and shorts the review period of the drug to six months, instead of the standard 10 month review.
Xarelto (rivaroxoaban) is part of a new generation of novel oral anticoagulants and was introduced in 2011, as an alternative to Coumadin (warfarin), which has been the go-to anti-clotting treatment for decades among individuals with atrial fibrillation. However, as more users have switched to the drug, thousands of Xarelto bleeding problems have been reported, since many doctors were unable to control or stop bleeds once they develop among users of the drug.
While all blood thinners carry a risk of bleeding, the side effects of warfarin can be quickly reversed with a widely known antidote. However, there was no Xarelto reversal agent when the drug was introduced.
According to allegations raised in more than 18,000 product liability lawsuits filed against the drug makers, consumers and the medical community were provided inadequate warnings about the potential side effects of Xarelto, including information about the lack of an antidote and the importance monitoring for the appropriate treatment dose.
Similar allegations were raised in thousands of Pradaxa lawsuits filed several years ago, as that medication hit the market before Xarelto. However, the maker of that competing drug ultimately agreed to pay $650 million in Pradaxa settlements just before the first bellwether trials were set to begin, with an average of about $150,000 per claim.
So far only two Xarelto trials have gone before a jury, each resulting in a defense verdict for the drug makers. However, additional cases are set for trial over the remainder of this year to help the parties gauge the relative strengths and weaknesses of their case. While the outcomes of these bellwether trials will not be binding on other plaintiffs, they may influence eventual Xarelto settlements that may be reached to avoid the need for thousands of individual trial dates in courts nationwide.