Hemorrhages And Gastrointestinal (GI) Bleeds Are Eliquis And Xarelto Side Effects That Can Cause Deaths
Eliquis and Xarelto are new anticoagulants, i.e., blood thinners, that -- unlike Coumadin (warfarin) -- do not require regular INR monitoring and dose adjustments.
Eliquis (apixaban) and Xarelto (rivaroxaban) are "factor Xa" drugs and they work differently from warfarin. These new blood thinners reduce thrombin production by inhibiting an enzyme called factor Xa instead of inhibiting vitamin K's clotting ability.
A real danger or problem that Eliquis and Xarelto share with another new blood thinner drug, Pradaxa (dabigatran), however, is the absence of an approved drug that can reverse their effects. That is, at the present time there is no antidote to stop serious bleeding events.
From a July 23, 2014 MedPage Today article, "Monitoring, Dose Adjustment for Pradaxa?", we get this important discussion about the safety issues surrounding Eliquis and Xarelto:
While there's no extensive data published to prove it, variability in blood concentrations is likely for the other newer oral anticoagulants -- such as apixaban (Eliquis), rivaroxaban (Xarelto), and edoxaban (Savaysa) -- too, according to a letter from Boehringer employee Paul Reilly, PhD, and RE-LY study authors in the Journal of the American College of Cardiology last month responding to criticism that data on dabigatran and plasma levels had been suppressed.
That is a point worth pursuing, Cohen argued.
"Rivaroxaban and apixaban were also marketed on the theme that plasma level dose adjustment was not needed, as it is with warfarin," she wrote. "More systematic and independent study is needed to establish what price, in terms of preventable hemorrhage and death, is being paid for each of the new drugs in the name of ease of use."
And who is this "Cohen" person?
For the answer to that question and some background as well as insight on this renewed drug safety controversy concerning Pradaxa, Xarelato, and Eliquis, we turn to a July 23, 2014 article by Larry Husten, "More Questions Raised About Boehringer Ingelheim's Pradaxa":
Once again dabigatran (Pradaxa) has raised the wrath of the critics. Several articles and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The BMJ, casts doubt on the reliability of the data supporting the drug as well as the behavior and decisions of regulatory authorities, trial investigators, and employees of Boehringer Ingelheim, the drug’s manufacturer. Although the articles focus on dabigatran, it is entirely possible that similar questions may also be raised about other new oral anticoagulants, including rivaroxaban (Xarelto, Johnson & Johnson) and apixaban (Eliquis, Pfizer and Bristol-Myers Squibb).
For those of you who want to read more in-depth about the various issues associated with serious bleeding side effects linked to Pradaxa, as well as Xarelto and Eliquis, below are the BMJ medical journal materials.
First, the Feature items:
- Dabigatran: how the drug company withheld important analyses
- Concerns over data in key dabigatran trial
Next, the Analysis item:
- Dabigatran, bleeding, and the regulators
Thomas J Moore, Michael R Cohen, and Donald R Mattison
And finally, the Editorial item:
- The trouble with dabigatran
Blake Charlton and Rita Redberg
We will continue to monitor the safety profiles of Eliquis and Xarelto as well as watch to see whether drug injury and death lawsuits concerning these new blood thinner products follow along the lines of the Pradaxa litigation, which was settled by Boehringer Ingelheim earlier this year.