Scientists associated with the British Medical Journal have voiced concerns regarding a clinical trial which may have led the U.S. Food and Drug Administration to approve the drug Xarelto in the United States.
What Is Rocket-AF?
Rocket-AF is the clinical trial which may have given the FDA reason to believe that the blood thinner Xarelto was safe for consumers. The trial compared Xarelto to Warfarin, and the results showed that the newer drug was as effective and safe as the older one. However, researchers are now saying that a device used during the trial may have skewed the results.
One of the devices used to measure the level of blood clotting during the trial has been recalled since that time for giving inaccurate readings. As a result, patients involved in the clinical trial may have been given more Warfarin than was necessary, resulting in excessive bleeding. Since Xarelto is a “one size fits all” type of drug which means all patients receive the same dose, it may have appeared that it was a safer option.
A professor of medicine at Yale University, Harlan Krumholz, stated that “The study should be considered of uncertain validity until a more thorough review can be done.”
Xarelto: The Risks
Blood thinners are not a new type of drug. Older versions like Warfarin, Fragmin, Lovenox, and Heparin have been used to treat patients with clotting disorders, pulmonary embolisms, and atrial fibrillation for decades. Xarelto, however, is one of the newest blood thinners to hit the market and, as many have come to find, a drug that has serious potential side effects.
Xarelto was approved by the U.S. Food and Drug Administration in 2011 for preventing blood clots and deep vein thrombosis in patients who had undergone a knee or hip replacement, for the treatment of atrial fibrillation, and as a treatment for those with clotting disorders. The drug, which was released into the U.S. market that same year, was heralded as a “wonder drug”.
Doctors and their patients embraced the drug because of one very exciting aspect – the dosage is the same for every single patient who takes it. Prior to Xarelto, patients had to return to their doctor frequently for blood testing in order to be sure that they were on the correct dosage. Age, weight, diet, and exercise levels all need to be taken into account. Some patients needed to return as often as once a week to have their dosage adjusted.
This new drug, however, doesn’t come without serious side effects. The most dangerous of these risks is the fact that Xarelto has no known antidote. That means that if a patient begins to bleed profusely, doctors can’t administer another drug to reverse the anti-clotting properties of the drug. This uncontrollable bleeding has resulted in the death of many patients. Those who have survived only did so because of the life-saving efforts of the doctors who typically perform a blood transfusion.
Others have reported side effects such as GI hemorrhaging, rectal bleeding, brain bleeds, pulmonary embolism, spinal bleeding, and stroke.
Today, thousands of lawsuits have been filed against Bayer AG and Johnson & Johnson, the manufacturers and distributors of the drug. Each one alleges that Xarelto caused serious injury or death in a patient who was prescribed the drug. Plaintiffs also allege that the manufacturers failed to warn the medical community and the public of the risks associated with the drug, and also failed to perform adequate safety testing.
These complaints were consolidated into MDL 2592 by the Judicial Panel on Multidistrict Litigation in December of 2014. The consolidation moved all federally filed lawsuits to a district court in New Orleans, Louisiana, under the honorable Judge Eldon Fallon.
The FDA’s Response
Despite the growing concern from both the medical community and the public, the FDA has not issued a recall of the drug. The administration has, however, published two safety communications which are known as “black box warnings”.
The first warning indicated that those who stopped taking the drug too quickly were at higher risk for conditions such as blood clots, DVT, and spinal hematoma. The second informed the public that the FDA had reasonable evidence that the drug was causing serious injury to patients who underwent a spinal procedure.
Plaintiffs are hopeful that with the new call to action by the British Medical Journal, both the manufacturers and the FDA will perform new independent clinical trials.