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The makers of the controversial anticoagulant Xarelto claim that new data from clinical trials could lead to approval for the drug to be used as a heart attack preventative, even as they face thousands of lawsuits over failing to warn about the risk of severe and often fatal bleeding injuries due to the lack of an available reversal agent.
On February 8, Bayer Healthcare and Janssen Pharmaceuticals, a division of Johnson & Johnson, reported that the third phase of clinical trials designed to test whether Xarelto was useful in preventing cardiac events was stopped early due to overwhelming success.
In a press release (PDF), the companies said that the Phase 3 Compass trials for Xarelto had been halted becaose the study had reached the pre-specified criteria for showing that the drug was effective for the prevention of heart attacks, stroke and cardiovascular death in patients with coronary artery disease (CAD) or peripheral artery disease (PAD).
“Despite established and effective treatments, incidences of CAD and PAD are rising globally,” Dr. Paul Burton, Vice President of Medical Affairs at Janssen, said in the press release. “We are excited about the possibility of making rivaroxaban available to patients with CAD and PAD to reduce their risk of major adverse cardiac events, and look forward to discussing the COMPASS trial data with the U.S. Food and Drug Administration as quickly as possible.”
The statement indicates that they plan to push for a new approval by the FDA that would give permission to the drug makers to promote Xarelto for heart attack prevention. However, it comes at a time of intense scrutiny on the drug, as side effects of Xarelto have been linked to thousands of incidents of uncontrolled bleeding and patient deaths.
Xarelto Bleeding Problems
Xarelto (rivaroxoaban) is a new-generation anticoagulant that was introduced in 2011, as an alternative to Coumadin (warfarin), which has been the go-to anticoagulant treatment for decades.
The drug is part of a new class of medications, which have been promoted as easier to use than warfarin. However, since the drugs have hit the market, there have been a large number of reports involving severe and sometimes fatal bleeding problems with Xarelto and other members of this new class, including Pradaxa and Eliquis.
While all blood thinners may cause 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.
There are currently more than 15,000 Xarelto lawsuits pending throughout the federal court system, which are all centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation.
Each of the cases raise similar allegations, indicating that the manufacturers withheld important information and warnings about the potential bleeding side effects of Xarelto, as well as the lack of an effective antidote that would have allowed doctors to reverse the blood thinning effects of the medication.
Plaintiffs allege that the drug makers failed to adequately warn doctors about the lack of an antidote, which led to severe and uncontrollable bleeds.
Similar claims were raised in the litigation over Pradaxa, which was the first member of this class introduced in October 2010, one year before Xarelto hit the market. About 4,000 Pradaxa lawsuits were ultimately filed by users of that drug who suffered bleeding injuries. Following several years of litigation, the manufacturer of that medication 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.
As Xarelto bleeding lawyers continue to review potential cases for individuals prescribed the anticoagulant throughout the United States, the number of complaints has surpassed the number of claims involved in the Pradaxa litigation, as the drug has become more widely used in recent years.