As Xarelto MDL Grows, Study Suggests Link with Hemorrhage

Laguna Hills, CAAs the number of Xarelto lawsuits included in the multidistrict litigation grows, a new study has been published suggesting a link between the use of rivaroxaban (the generic of Xarelto) and spontaneous eye hemorrhage, also known as bleeding in the eye. Lawsuits have been filed against the makers of Xarelto, alleging patients were not adequately warned about the risks associated with taking the drug.

The most recent study was published June 25 in JAMA Ophthalmology. Researchers found a correlation between use of rivaroxaban and a risk of spontaneous vitreous hemorrhage, although they noted that all three patients who developed the eye hemorrhage were also taking an additional anticoagulant at the time.

“The risk of hemorrhage may be particularly elevated during the transition period when patients are switched from baseline anticoagulant to rivaroxaban therapy and are taking both anticoagulants simultaneously,” researchers wrote.

According to Reuters (6/26/15), all three patients who experienced vitreous hemorrhage were males over the age of 70 who experienced the hemorrhage in their right eye. All three were taking warfarin and rivaroxaban at the same time and all three discontinued the warfarin when the hemorrhage developed. All three recovered from the hemorrhage within two months of the event and did not suffer any significant vision damage.

Meanwhile, a study published in BMJ in April suggests patients who are treated with rivaroxaban could be at as much as double the risk of gastrointestinal bleeding compared with patients who take warfarin. Researchers noted that when they didn’t adjust for other factors, there was no statistically significant difference in the rate of bleeding between the two groups.

“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out…a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.”

As lawsuits filed against the makers of Xarelto work their way through the courts, more lawsuits are being added to the multidistrict litigation. As of July 15, 2015, 805 lawsuits had been consolidated in MDL 2592 (In Re: Xarelto Products Liability Litigation) before US District Judge Eldon E. Fallon. In June there were 552 such lawsuits consolidated. Consolidation for pretrial proceedings is not a comment on the merits of the lawsuits, it is an acknowledgement that the lawsuits share similar questions of fact.