The author of a new editorial published this month in the Journal of the American Medical Association (JAMA) is questioning the current dosage recommendations for new-generation anticoagulants such as Xarelto. In the editorial, Dr. J. Robert Powell of the Eschelman School of Pharmacy at the University of North Carolina, Chapel Hill, writes that patients might benefit from individualized dosage, rather than the one-size-fits all approach now touted by the drugs’ manufacturers.
Sales of Xarelto and other new blood thinners have been driven by marketing claims that boast of their superiority over warfarin, an anticoagulant that has been on the market for decades. Among other things, the drug companies assert that these new options are safer and require less blood monitoring. However, there currently exists no approved antidote to stop internal bleeding associated with Xarelto and similar medications. Warfarin bleeding, by contrast, can be stopped via the administration of Vitamin K.
In his JAMA editorial, Dr. Powell expresses concern about the marketing claims surrounding new blood thinners like Xarelto.
“It is not a coincidence that 3 US-marketed DOACs share the same strategy of 1 dose for all patients and no need for laboratory testing,” he wrote. “This is in part the marketing profile each company used at the drug discovery phase that then guided development decisions through phase 3 trial design, execution, and New Drug Application submission.”
The publication of the JAMA editorial comes as thousands of people pursue Xarelto lawsuits for injuries and complications allegedly related to uncontrollable bleeding related to its use. Among other things, these lawsuits question marketing claims that highlighted the medication’s supposed superiority over warfarin, and assert that patients using the new blood thinner would benefit from regular blood monitoring and individual dosing regimens. They also claim that patients and doctors were not adequately warned that Xarelto bleeding could not be easily reversed.