Advertisements As Well As Prescribing Information / Drug Label Seem To Downplay The Fact That There Is No Reversal Agent For Eliquis, Yet
(Posted by Tom Lamb at DrugInjuryWatch.com)
In print advertisements for their relatively new blood thinner medicine Eliquis, Bristol-Myers Squibb and Pfizer state in the Important Safety Information section ("August 2014" version):
ELIQUIS can cause bleeding, which can be serious, and rarely may lead to death.
But at the very start of these print ads, in larger print, is this point -- #2 of "3 GOOD REASONS":
ELIQUIS has less major bleeding than warfarin.
If one delves further into the Eliquis advertisements you may see in popular magazines, you will find this:
While taking ELIQUIS... it may take longer than usual for any bleeding to stop.
What you will not see, however, is any statement to the effect that there is no reversal agent to stop a serious bleeding event that may happen while a patient is on Eliquis. That is, Bristol-Myers Squibb and Pfizer do not state in these advertisements that there is no FDA-approved antidote for Eliquis as regards its blood-thinner effect at this time.
Put simply, there seems to be a failure to warn patients that the risk of death is higher once one starts to bleed due to a traumatic event, for example.
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To be clear, the Prescribing Information for Eliquis from Bristol-Myers Squibb and Pfizer ("Rev August 2014" version) -- which is usually only seen by medical doctors and, perhaps, other health care providers -- says this in the Warnings And Precautions section:
There is no established way to reverse the anticoagulant effect of [Eliquis apxiaban)], which can be expected to persist for at least 24 hours after the last dose, i.e., for about two drug half-lives. A specific antidote for ELIQUIS is not available.
Instead, the drug company could perhaps tell all of us that the risk of death is higher once patients using Eliquis start to bleed due to a traumatic incident, or an unrecognized internal bleeding event, such as a gastrointestinal (GI) bleed.
Accordingly, it was good to see the recent news reports and a drug company press release that there are some apparent developments in getting an Eliquis antidote approved by the FDA and, ultimately, available for us with patients who need it.
Here is one of the recent news reports, "ANNEXA-A: Antidote reversed anticoagulant effect of apixaban", published on December 15, 2014:
Andexanet alfa safely and effectively reversed the anticoagulant effects of [Eliquis (apixaban)] among older patients, according to data presented at the American Heart Association Scientific Sessions [in Chicago].
And as regards the Bristol-Myers Squibb and Pfizer press release, "Anticoagulant Effect of Eliquis (apixaban) Reversed by Two Separate 4-Factor Prothrombin Complex Concentrates in Healthy Subjects".
But this movement towards a possible Eliquis antidote is too late in some of the Eliquis drug injury cases which we are currently investigating, including these:
- 79 year old woman - Internal Bleeding and Rectal Bleeding; hospitalized 6 days
- 52 year old man – Gastrointestinal (GI) Bleed; hospitalized 8 days
- 76 year old woman - Hemorrhagic Stroke / Irreversible Bleeding Event; Death
- 79 year old man – Serious Internal Bleeding; Death
While we hope there will be an Eliquis antidote available soon for those patients who may need it, unfortunately it comes too late for some who did -- but it was not available, with tragic consequences.
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