Report: More than 15,000 Adverse Events Linked to Xarelto in 2016

JACKSON, Miss., July 25, 2017

According to ISMP, the U.S. Food and Drug Administration received 15,043 reports of serious injury or death linked to Xarelto last year — a 41 percent increase over the previous year.

ISMP, a non-profit organization that monitors and analyzes adverse drug events reported to the government, published the findings in its annual edition of QuarterWatch. 

Oral blood thinners such as Xarelto caused more emergency room visits in 2016 than any other class of drugs, ISMP found. The group said it identified nearly 22,000 reports of severe injury, including 3,018 deaths. Nearly all of the injuries were from internal bleeding, the report states. Of the five anticoagulants implicated, rivaroxaban, sold under the brand name Xarelto, accounted for 68.4 percent of all adverse events in 2016, according to ISMP.

The report comes as the first trials in litigation against Xarelto get underway. More than 18,000 lawsuits against the makers of Xarelto have been centralized under the federal multidistrict litigation (MDL) process that uses "bellwether" trials to establish evidence and determine any settlement value for similar plaintiff claims.

"These injury findings are disheartening, but unfortunately not all that surprising," said Andy Birchfield of the Beasley Allen law firm and co-lead counsel of the plaintiffs' steering committee for the Xarelto MDL. "The statistics are testament that Xarelto is one of the most high-risk drug treatments in medicine today, and the reason we are pursuing justice for the victims of this potentially deadly medication."

Johnson & Johnson (NYSE: JNJ), Janssen Pharmaceuticals and Bayer Healthcare (OTC: BAYRY) are accused of downplaying the risks of taking Xarelto and aggressively marketing the drug as an alternative for warfarin in patients needing blood thinners to reduce the risk of dangerous clots. The companies positioned the drug as more convenient, calling for a once-a-day dose and eliminating the need for regular monitoring of a patient's blood. However, the lawsuits charge that doctors and patients were not fully informed of the risks.