Witness: Xarelto is “The Worst” of All Anticoagulents

Frank W. Smart, MD
Frank W. Smart, MD, testified that Xarelto should have an FDA Black Box Warning — the strongest warning.

In damning testimony against drugmakers Janssen Pharmaceuticals and Bayer, an expert cardiologist testified at the second Xarelto bellwether trial that of all the anticoagulants, Xarelto is “the worst.”

“So Xarelto, of all the new oral anticoagulants, is the worst. And that’s well established in the medical literature and even by the FDA. The FDA said that Xarelto was equal to Coumadin. The other drugs which would be apixaban or Eliquis, dabigatran or Pradaxa and edoxaban or Savaysa are in one shape or form superior either in anticoagulation effect or in bleeding or in both,” testified Frank W. Smart, MD, a board-certified doctor in cardiology at LSU School of Medicine.

The case is  In Re: Xarelto (Rivaroxaban) Products Liability LitigationJoseph Orr v. Janssen Research, Case No. 2:15-CV-3708, before US District Judge Eldon Fallon in the Eastern District of Louisiana. Plaintiff attorney Anthony Birchfield, Jr. of Beasley Allen Crow Methvin Portis & Miles in Montgomery, AL, led the direct examination.

Dr. Smart’s  opinion was based on his own research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, and transcripts of FDA reviewers’ opinions FDA where the Xarelto was discussed.

Stops precribing Xarelto

Xarelto is a NOAC or new oral anticoagulant. Instead of blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-to-thrombin conversion and thins a person’s blood.

“I read an article that was in one of the Canadian journals that was very impressive to me, and I started transitioning people off of Xarelto at that time and have completely abandoned the use of it,” he testified. “It was a twice-a-day drug crammed into a once-a-day prescription, and I thought that that was a poor idea. I still think it’s a poor idea.”

“A practicing cardiologist sees people six, seven days a week “and they don’t have time. They don’t physically have time to chase down information like this.”

“Coumadin has a black box warning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and then things like that. Xarelto, I believe, should have a black box warning as well because all the literature and the FDA said that there’s no difference,” he testified.

An FDA Black Box Warning is the strongest warning that the US Food and Drug Administration (FDA) puts on a drug. For example, addictive opioids have black box warnings.

After reading FDA transcripts, Smart said, “The conclusion seemed to be that if the FDA had had their druthers, the company would have tested a twice-a-day dose, but they went on to say that they didn’t have the capacity to force the company into doing that, and the only thing that they could do was to consider the information that had been presented to them at the once-a-day dose.

Xarelto worst drug in its class

The ROCKET-AF trial of Xarelto on 7,000 patients with atrial fibrillation (Afib) found that “Xarelto was the worst in the class of these drugs. It was never shown to be superior to warfarin for either stroke or bleeding. But Eliquis, or apixaban, was shown to be superior for both,” Smart testified.

Q. (by attorney Anthony Birchfield) So when we look at these drugs, if we look at Eliquis.  Eliquis in the clinical trial, is it shown to be superior in both safety and efficacy?

A. (by Dr. Smart) Yes, sir. To warfarin.

Q. So Eliquis is superior to them both. And then, when we look at Pradaxa compared to warfarin, was Pradaxa — was it superior to either — in either safety or efficacy?

A. Yes, sir. It was superior in safety.

Q. What about efficacy?

A. Equal.

Q. And then, when we look at Xarelto was Xarelto superior in safety?

A. No, sir.

Q. Was it superior in efficacy?

A. No, sir.

“I think, again, playing Monday morning quarterback, I think had Eliquis been released at the time, there was no way that Xarelto would have been approved,” by the FDA, Smart testified.

“It’s worst in class among the NOACs. That’s pretty accepted. I mean, it’s a four-horse race, and they are the fourth horse. This adds concern that the approval was maybe less grounded in great science.”

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Eliquis State-Law Claims Preempted, MDL Case Dismissed

eliquis-internal-bleeding-lawsuitA federal judge in New York dismissed one of 49 cases brought against Bristol-Myers Squibb Company and Pfizer Inc. over their Eliquis anticoagulant, ruling that the plaintiff’s state-law claims were preempted by federal law.

Granting a motion to dismiss, Judge Denise Cote threw out Utts et al v. Bristol-Myers Squibb Company et al, case number 1:16-cv-05668, in the U.S. District Court for the Southern District of New York, In Re: Eliquis (Apixaban) Products Liability Litigation, MDL No. 2754.

The court said that all the plaintiff’s claims — for failure to warn, design defect claims, warranty violations, fraud, and consumer protection claims — were preempted, adding that the Eliquis label is adequate as a matter of law.

Not ‘newly acquired information’

Showing off her homework in an 85-page opinion, Judge Cote also rejected all nine scientific articles or documents cited by the plaintiffs to create a plausible claim that the Eliquis labeling fails to adequately warn of the risk of excessive bleeding. “The information contained in this literature does not constitute ‘newly acquired information’ under the FDA’s regulation,” the opinion says. “Accordingly, the plaintiffs’ claims are preempted because federal law would not have permitted the defendants to make any change to the Eliquis label.”

“The risk of excessive bleeding from this blood thinner and the lack of an antidote were clearly disclosed to the Food & Drug Administration (“FDA”) when it approved the drug, and are prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug,” the judge says.

Charlie Utts of California was diagnosed with atrial fibrillation and prescribed Eliquis by his doctor. After taking Eliquis, he suffered severe gastrointestinal bleeding and was hospitalized in July 2014 for about three weeks to undergo blood transfusions and several rounds of dialysis. He and his wife filed suit in 2016.

Eliquis — the brand name of the prescription medicine apixaban — is a blood-thinning medication used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Eliquis belongs to a class of drugs known as novel oral anticoagulants (“NOACs”). It does not have a known antidote or reversal agent. Unlike anticoagulant medications such as warfarin, NOACs, including Eliquis, do not require periodic blood testing or impose dietary restrictions on users.

Eliquis was approved by the FDA in 2012. The judge said the Eliquis label warns about the risk of serious bleeding five times, and warns that there is no specific antidote two times.

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