This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.
Published on Monday, December 21, 2015 by Staff
A recent study that looked at Department of Defense electronic medical records was reported in poster fashion at a recent meeting of the American Heart Association. The study focused on the risk of fatal bleeding in patients with atrial fibrillation (A-Fib) who were taking Xarelto® (rivaroxaban). The study compared patients who did not have kidney disease to those who did.
According to a recent article published by Medpage Today, the study researchers reported that the rate of fatal bleeding “was almost identical for patients with or without renal disease” who were taking Xarelto®. The researchers reported incident rates of 0.09 per 100 person-years for both groups of A-Fib patients. The lead researcher, Capt. Sally Tamayo, M.D. head of cardiology at the Naval Medical Center in Portsmouth VA, is quoted as having commented that “I think it is reassuring that the mortality is the same for both people with renal disease and for those who do not have renal disease but who are on rivaroxaban [Xarelto].” It is unclear who is reassured by this – patients or researchers?
Importantly, the study results also demonstrate the heightened risk of major bleeding faced by Xarelto patients with renal disease. According to these same researchers, the incidence rate of major bleeding for A-fib patients with renal disease was 4.52 per 100 person years as compared to a rate of 2.54 per 100 person years for those without renal disease. This represents a 78% higher incidence rate for major bleeding among patients with kidney disease (4.52-2.54/2.54). Importantly, almost half of the patients with kidney disease (49.7%) were taking a lower dose of Xarelto® (15mg or 10mg) than those patients without kidney disease.
While the researchers appear to have focused primarily on fatal bleeding rates, i.e. how likely a patient will die, perhaps greater focus is needed on the increased likelihood that a patient with kidney disease has for experiencing a major bleeding event in the first place. Further study and analyses of these results should reveal more about this increased risk.
This litigation has concluded and we are proud to report that our clients' claims have been successfully resolved. The amounts of all individual client recoveries are confidential, both by settlement agreement and by attorney-client privilege. MLG is no longer accepting cases involving this product.