In an extremely hard-hitting testimony against drug manufacturers Janssen Pharmaceuticals and Bayer, Frank W Smart, MD, board-certified doctor in cardiology at LSU School of Medicine testified at the second Xarelto bellwether trial that of all blood thinners, Xarelto is “the worst.”
Dr. Smart’s Testimony
Dr. Smart testified, “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.” The case is before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.
Dr. Smart’s opinion was based on his personal research plus internal company e-mails from drug manufacturers Janssen Pharmaceuticals and Bayer, as well as transcripts of U.S. Food and Drug Administration (FDA) reviewers’ opinions where Xarelto was discussed.
Xarelto is a new oral anticoagulant (NOAC). Rather than blocking clotting factor Vitamin K, Xarelto is an inhibitor of Factor Xa, and it too stops the prothrombin-thrombin conversion and thins an individual’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,” Dr. Smart 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.”
National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation, including Xarelto and other anticoagulants. Attorneys at the firm are available to answer questions for any individuals seeking legal information for a potential lawsuit
Black Box Warning
“Coumadin has a black box waning that says: Bleeding is an issue. You really need to focus on this. Be careful. Monitor it, and 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,” Dr. Smart testified.
A Black Box Warning is the strongest warning that the FDA puts on a drug. For example, addictive opioids have black box warnings.
Subsequent to 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 was tried on 7,000 patients with atrial fibrillation (Afib) in a trial called the ROCKET-AF. It was 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.
When asked if Eliquis in a clinical trial, is shown to be superior in both safety and efficacy, Dr. Smart believes it is superior and names warfarin (Coumadin) as the better option. When Pradaxa was compared to warfarin, Dr. Smart agreed Pradaxa was superior in safety to Eliquis and warfarin, and both tested equal for efficacy. When compared to Xarelto, Dr. Smart said Xarelto was inferior in both safety and efficacy to warfarin and Pradaxa.
“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 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,” reports Law360.
The anticoagulant Xarelto was brought to market in 2011 by Johnson & Johnson in collaboration with Bayer HealthCare. Xarelto’s competition was its predecessor, Pradaxa that was released in 2010. Pradaxa was the first blood thinner to be released since warfarin was made available in the 1950s.
Anticoagulants work by inhibiting the body’s blood clotting mechanism to increase circulation efficiency and to avoid possibly fatal blood clots. The problems arise, however, because blood thinners also inhibit the body’s ability to heal itself from internal bleeding episodes.
Legal Help for Xarelto Users
If you or someone you know has been negatively affected by an anticoagulant including Xarleto, you may have valuable legal rights. Parker Waichman LLP offers free, no-obligation case evaluations. We urge you to contact our personal injury attorneys at 1-800-YOURLAWYER (1-800-968-7529).