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).
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 (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.
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.