Two professional journal articles released during the week of June 15 underscore the reason that patients who used the anticoagulant Xarelto suffered serious injury. Those scholarly pieces also somewhat vindicated victims or the family members of decedents who have filed Xarelto lawsuits.
The journal Arteriosclerosis Thrombosis and Vascular Biology published one of last week's Xarelto medical reviews. Released June 18, the Canadian and British authors addressed the search for an agent that would allow surgeons or emergency medical personnel to reverse Xarelto bleeding. Actually, the authors discussed the importance of finding an antidote for several newfangled anticoagulants, writing from the outset, "Their main disadvantage is currently the absence of a specific reversal agent."
The authors delved into the track records of several agents that might someday be able to stop Xarelto bleeding and bleeding linked to the use of several other anticoagulants. Apparently, more progress needs to be made.
"Prothrombin complex concentrate, activated prothrombin complex concentrate, and recombinant factor VIIa all show some activity in reversing the anticoagulant effect of these drugs but this is based on ex vivo, animal, and volunteer studies," authors wrote, adding, "It is unclear, which, if any, of these drugs is the most suitable for emergency reversal."
The second of these two pieces is more damning in that it compares the bleeding risk shown in a major clinical trial with the bleeding risk determined anecdotally by physicians who treat the patients. The comparison was significant because one of the issues in Xarelto lawsuits was how much the drug's manufacturer, Johnson & Johnson's Janssen Pharmaceuticals, knew about the bleeding risk as well as the extent to which it informed consumers and physicians about that risk. (There are additional defendants.)
Researchers in Tennessee, writing for the journal Pharmacotherapy, established the purpose of their study from the outset, referring to the RECORD clinical trials upon which the manufacturer could base favorable claims about Xarelto safety. The generic version of Xarelto is known as rivaroxaban.
"Although data from the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Venous Thrombosis and Pulmonary Embolism (RECORD) 1-4 trials have shown a similar postoperative bleeding risk between rivaroxaban and enoxaparin in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA), anecdotal observations from local institutions have suggested that postoperative bleeding rates seemed higher in patients who received rivaroxaban than those reported in the RECORD trials," authors wrote in an article that Pharmacotherapy released June 19. "Thus, the objective of this pilot study was to assess postoperative bleeding events observed in clinical practice in patients receiving rivaroxaban after undergoing THA and TKA and to compare their results with those published in the RECORD trials."
Xarelto's actual "record" speaks for itself.
As the authors explained, "Any postoperative bleeding occurred in 6.8 percent of the cohort patients versus 3.2 percent of the RECORD trial patients..."
They concluded, "Overall, any postoperative bleeding in the cohort patients occurred significantly more frequently than that observed in the RECORD trial patients ... These findings from our pilot study are thought provoking and, thus, invite further investigation."
Sunday will mark the third anniversary of the death of a Florida man who passed away about five months after starting Xarelto. He suffered a subdural hemorrhage. Physicians at a hospital near Philadelphia operated on him five days before his death and tried to stop the bleeding; he didn't make it.
In its complaint, the victim's family claims, "By failing to warn Decedent and Decedent's physicians of the adverse health risks associated with Xarelto, Defendants breached their duty to Decedent of reasonable care and safety. ... Defendants, as manufacturers and distributers of pharmaceuticals drugs, are held to the level of knowledge of an expert in the field; and further, Defendants knew or should have known that warnings and other clinically relevant information and data which they distributed regarding the risks of irreversible bleeds and other injuries and death associated with the use of Xarelto were inadequate."
Anyone who suffered a serious bleeding event after using Xarelto may indeed have a case.