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Eliquis Side Effects: What The Warning Label Doesn’t Say

Where effectiveness is concerned, the new blood thinner Eliquis has been praised for its ability to prevent blood clots better than warfarin. But safety is another question.

Eliquis Side Effects What The Warning Label Doesn't Say

While the drug’s warning label mentions a risk of “bleeding,” and even says the bleeds caused by Eliquis can be “serious [or] potentially fatal,” a growing body of critics thinks that warning isn’t good enough. In fact, several lawsuits claim that Eliquis’ manufacturers failed to warn the public adequately of Eliquis side effects.

Does Major Blood Thinner Have Deadly Side Effects?

In choosing to take a medication, most patients have two competing concerns: efficacy and safety. Doctors weigh the benefits promised by a new medication against its potential side effects in making their prescribing decisions. Ideally, benefit will outweigh risk, suggesting the drug may be a good option.

But other alternative drugs need to be considered, too. Warfarin (sold as the branded product Coumadin) has been used as an effective anticoagulant for over 60 years. While it presents a risk of excessive bleeding like any other blood thinner, it can be paired with an antidote in emergency situations. A variety of reversal agents can effectively “thicken” a patient’s blood, preventing the possibility of an irreversible bleed.

Blood Thinners Present Bleeding Risk, But There’s No Antidote For Eliquis

This is a significant benefit of warfarin not shared by Eliquis. Even though the drug was approved nearly three years ago, Eliquis remains without an antidote.

The active ingredient in Eliquis is called apibaxan. That’s a “direct factor Xa inhibitor,” which means it knocks out a specific chemical that helps blood coagulate.

In a series of major Eliquis lawsuits, patients who took the drug and then suffered severe bleeding events say Bristol-Myers Squibb and Pfizer, the two companies behind Eliquis, failed to highlight the drug’s lack of a reversal agent. In their minds, this “failure” led physicians to overestimate the benefits of apibaxan, while ignoring its potentially-fatal side effects.

Were Patients & Doctors Deceived Into Choosing Eliquis?

Patients were deceived, too, they allege. Bristol-Myers Squibb and Pfizer began an aggressive direct-to-consumer marketing campaign almost immediately after Eliquis’ approval. Featuring smiling middle-aged adults and simple statements like “Reduces Risk Of Stroke Due To AFib,” these advertisements didn’t mention that the drug’s blood-thinning effect could never be reversed.

It was a two-pronged marketing approach, Plaintiffs claim. First, bury crucial prescribing information deep in Eliquis’ warning label. Then, deceive consumers about its significant disadvantage, the one point on which warfarin had Eliquis beat hands-down: the lack of an antidote.

 

To date, the “Warnings & Precautions of Eliquis’ label contains no mention of a reversal agent. But that’s exactly where Plaintiffs think it belongs. Better warnings could have led doctors to go for proven methods of preventing stroke and heart attack, like warfarin – and prevented unnecessary deaths.

What The Warning Label Does Tell You

On its warning label, Eliquis is explicitly linked to three major types of bleeding event:

  1. Gastrointestinal bleeding : bleeds that begin in the rectum, colon, stomach and small and large intestines
  2. Intracranial bleeding : an accumulation of blood on the brain
  3. Intraocular bleeding : bleeding in the eyeball

 

In addition, statistics gathered in an early clinical trial suggest a number of fatal bleeds. The Mayo Clinic lists a number of additional side effects linked to Eliquis, including:

  • swelling near eyes and lips
  • swollen tongue, difficulty swallowing
  • constipation
  • severe belly pain
  • nausea, vomiting
  • bruises or other skin reactions, hives
  • disorientation
  • inability to concentrate
  • dizziness, fainting
  • accelerated heart rate
  • blood in urine
  • blood in eyes
  • nosebleeds (or “epistaxis”)
  • blood in stool (often looks black, not red)
  • vomiting blood

Fatigue does not appear to be an observed side effect of Eliquis.

Increased Risk Of Blood Clots

One of Eliquis’ most serious side effects actually comes after patients stop taking the drug. In what medical professionals sometimes call a “rebound” effect, abruptly ending treatment can increase a person’s risk for developing blood clots.

Eliquis should never be discontinued suddenly.

Does The Dosage Matter?

Dosage matters a lot. In fact, one of Eliquis’ key selling-points was that the drug had a “one-size-fits-all” dosage. Warfarin, on the other hand, requires exacting dose management and diet restriction. Too much Warfarin and patients could suffer from internal bleeding; too little and it won’t have the desired anticoagulant effect.

Eliquis changed all that. Bristol-Myers Squibb and Pfizer pushed hard on the fact that Eliquis patients wouldn’t need routine blood monitoring. The drug was simply more convenient than traditional blood thinners, its manufacturers claimed.

For some patients, that may be true. But holes have begun to appear in the Eliquis story, and more may be waiting for unsuspecting aFib patients. For one, people with kidney problems do require dose management since dialysis has proved an insufficient way of removing high concentrations of the drug from the bloodstream.

Lawsuits Expected As Bleeding Risks Become Clear

Many members of the legal community believe that Eliquis will soon be faced by its own wave of bleeding lawsuits, just like similar medications Pradaxa and Xarelto before it. Bristol-Myers Squibb and Pfizer have been confronted by damning allegations, and many patients, along with survivors who live on in the absence of their loved ones, may be entitled to financial compensation. Our experienced Eliquis lawyers are here to help.