Xarelto Defense Attorney trembles as FDA and EMA review ROCKET-AF Trial

By | December 9, 2015

All the Xarelto injury lawyers who brought Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson) before the United States District Court for the Eastern District of Louisiana for the Xarelto Multi-District Litigation now rejoice. The Xarelto defending attorney should be scared, in fact, as the largest trial that demonstrated Xarelto safety and effectiveness is now under review by the Food and Drugs Administration (FDA) and the European Medicine Agency (EMA).

Xarelto injury lawyers accused the drug manufacturers of negligence in warning patients about the alleged risks of using this medication, which is associated with an increased risk of life-threatening side effects such as uncontrolled bleeding and internal hemorrhages. The blood-thinner medication from J&J is in fact one of the most dangerous medication in the actual market, no matter if it’s advertised as a “safe medication.” The absence of a Xarelto antidote, in fact, prevents doctors and health providers to revert its lethal effects once a bleeding event occurs. Anyone who looked for a Xarelto injury lawyer to bring his case to a tribunal either suffered a serious injury or is the relative of a patient who died because of the Xarelto adverse reactions described above.

Against Xarelto Recall Attorney however, Bayer AG always claimed their product’s safety since the FDA granted its approval a few years ago. The principal clinical that determined Xarelto safety was the ROCKET-AF trial, that in 2011 convinced FDA that this blood-thinner could be safely used for the prevention of strokes and blood clots in people who suffered from atrial fibrillation. The ROCKET-AF trial compared Xarelto to Warfarin, the oldest medication used as a standard treatment for this kind of conditions. To determine both drugs’ effectiveness in reducing the ability of the blood to clot, researchers had to determine a value called “International Normalized Ratio” (INR). The higher this value was, the longer it required for the blood to clot, and consequently, the more efficient the drug was. To check the INR in patients under either Warfarin or Xarelto treatment, scientists used a device called INRatio Device. The problem is: that device was faulty.

Back in 2005 and 2006 the FDA sent two warning letters explaining that the INRatio Device often sported erroneous readings, until in 2014 the device was recalled. It is unclear whether the malfunctioning device could skew the results or not, and that’s what FDA and EMA are investigating at the moment. It should be noted however, that no mention of the INRatio Device mistakes was made during FDA’s Xarelto review process in 2011. However, during the advisory committee meeting in that same year, FDA itself apparently recommended against Xarelto approval unless the medication showed at least the same effectiveness as Warfarin. So, what’s happening here exactly?

As any Xarelto lawyer may have noticed, the above trial was run by Dr. Robert Califf, President Barack Obama’s current nominee for FDA Commissioner. Califf’s transparency is now under the microscope, as his strong ties to the pharmaceutical industry already generated much controversy in the recent past. Could Califf be considered like a “Xarelto Recall Attorney” who defended the drug for its own gains? This is a serious accusation, but it’s clear to understand how much is at stake here with Obama reaching the end of his mandate. He personally acknowledged the role of pharmaceutical companies in funding several studies he oversaw during his career at Duke University. However, during the Senate confirmation hearing Califf stated that no Big Pharma ever asked him to hide or change the results of the studies.

The Democratic presidential candidate, Senator Bernie Sanders of Vermont, already claimed he’s not going to support him because FDA needs a more “aggressive commissioner.” Sanders wants a candidate who’s able to stand up against the pharmaceutical companies, as the US judicial system has always been quite “weak” in taking on them. Other senators like Democratic Senator Elizabeth Warren of Massachusetts instead provided a more balanced approach to Califf’s nominee, who explained during the hearing that he was going to raise FDA safety standards.

Article by Dr. Claudio Butticè, PharmD.

REFERENCES

  1. Kaplan, Sheila. “Robert Califf: I’ll never lower FDA standards“. STAT. Nov. 17, 2015
  2. Patel, Manesh R.; Mahaffey, Kenneth W.; Garg, Jyotsna; Pan, Guohua; Singer, Daniel E.; Hacke, Werner; Breithardt, Günter; Halperin, Jonathan L.; Hankey, Graeme J. (2011-09-08). “Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation”. New England Journal of Medicine 365 (10): 883–891. doi:10.1056/NEJMoa1009638. ISSN 0028-4793. PMID 21830957.
  3. FDA U.S. Food and Drug Administration Website: “MEDICATION GUIDE XARELTO® (zah-REL-toe) (rivaroxaban) tablets” Reference ID: 3688029 http://www.fda.gov/downloads/drugs/drugsafety/ucm280333.pdf (Accessed June 2015):
  4. “Bleeding with dabigatran, rivaroxaban, apixaban. No antidote, and little clinical experience.” Prescrire Int. 2013 Jun;22(139):155-9.
  5. Institute for Safe Medication Practices (ISMP) “ISMP List of High-Alert Medications in Acute Care Settings” https://www.ismp.org/tools/highalertmedications.pdf (Accessed June 2015)