A Reversal Agent For Eliquis Currently Under Development Comes Too Late For People With Trauma-Induced Bleeding Incidents, Some Who Bled To Death
(Posted by Tom Lamb at DrugInjuryWatch.com)
UPDATE: Eliquis Antidote Will Come Too Late For People Who Suffered Serious Bleeding Events, Some Which Caused The Deaths Of Patients
Advertisements As Well As Prescribing Information / Drug Label Seem To Downplay The Fact That There Is No Reversal Agent For Eliquis, Yet
Eliquis (apixaban) was the last of the three "new-generation" anticoagulants to make it to the market. It was approved by the FDA in 2012. Pfizer and Bristol-Myers Squibb are the two drug companies which share the profits and responsibility for Eliquis.
The first such new blood thinner released was Pradaxa (dabigatran), a direct thrombin inhibitor by Boehringer Ingelheim. Next came Xarelto (rivaroxaban) by Johnson & Johnson, which was approved in 2011.
Significantly, none of these three blood thinners -- Pradaxa, Xarelto, and Eliquis -- currently have an approved antidote for a patient experiencing a trauma-induced bleeding event or needing emergency surgery.
We wrote about this drug safety problem in this article, "Eliquis And Xarelto, Like Pradaxa, Linked To Serious Bleeding Events Due To Fact No Antidote Available", which we posted back in September 2014.
Now we have an update on this drug safety situation as regards Eliquis, at least.
We start with the fundamental fact that Eliquis is a Factor Xa inhibitor.
In response to the "no-antidote" Eliquis issue, the company Portola Pharmaceuticals has developed a new product, Andexanet alfa, which reverses the effects of Factor Xa inhibitors.
Strictly Confidential, No Obligation.
Not surprisingly Portola is collaborating with Pfizer and Bristol-Myers Squibb on the product's development insofar that Eliquis sales numbers would likely increase with Portola's new Xa antidote coming on the market.
From a November 17, 2014 Seeking Alpha business news report, "Adexanet Alfa reverses anticoagulant effect of Eliquis in first stage of Phase 3":
In the first part of the ANNEXA-A Phase 3 study, andexanet alfa produced a rapid and almost complete reversal (94%) (p<0.0001) compared to placebo of the anticoagulant effect of Eliquis (apixaban) in healthy volunteers ages 50 - 75 as measured by anti-Factor Xa activity. The results will be presented today at the American Heart Association meeting in Chicago.
Given that Xarelto is a Factor Xa inhibitor, also, this advancement by Portola with its new Xa antidote shoud benefit Boehringer Ingelheim, which has been the subject of recent lawsuits concerning serious bleeding events, some of which have been fatal.
Although Xarelto lawsuits are getting more attention, including law firm TV ads, Eliquis cases for side effects such as trauma-induced atypical and irreversible bleeding events have the same factual basis: lack of an effective reversal agent, or antidote.
We are investigating Eliquis-related death cases which involve excessive bleeding as well as other Eliquis side effects such as gastrointestinal (GI) bleeds, rectal bleeding, and brain hemorrhages or intracranial hemorrhages.
To reiterate, as stated in the above Seeking Alpha report:
Currently, there is no antidote to Eliquis despite the need for a method to reverse its anticoagulation effects in certain clinical situations such as a major bleeding event or emergency surgery.
While Portola's Factor Xa antidote will someday help patients suffering an acute bleed, and should lead to fewer Xarelto and Eliquis lawsuits in the future, unfortunately, its eventual and much anticipated FDA-approval is too late for some people who suffered serious bleeding events or bled to death, already.
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