A new research sheds some light on Xarelto’s lack of safety, showing how its side effects are the most dangerous among the new generation of blood thinners. According to the study published in the science journal Gastroenterology, rivaroxaban is the least safe among the Novel Oral Anticoagulants (NOACs) a category of new controversial medications that includes Pradaxa (dabigatran) and Eliquis (apixaban). Researchers from the Mayo Clinic investigated which NOAC had the most favorable safety profile in terms of risk of gastrointestinal bleeding by directly comparing the three new alternatives of Warfarin, the oldest and most consolidated anticoagulant. The safety and effectiveness data of the three drugs was collected by searching through data extracted from Medicare Advantage patients and the OptumLabs Data Warehouse of privately insured subjects. In each direct comparison, data from at least 13,000 individuals affected by non-valvular atrial fibrillation has been used to make a direct comparison.
The results of the study left little space for doubt: with a hazard ratio of 1.20 Xarelto was the most dangerous blood thinner, while Eliquis was the safest one with a hazard ratio of just 0.33. The risk of internal hemorrhages was further increased among in elderly patients aged 75 years or more, and the first gastrointestinal bleeding accident usually happened within the first 90 to 120 days of treatment. However, one of the most controversial aspects of the therapy with the new generation of anticoagulants is the absence of a proper antidote to reverse their effects whenever a serious bleeding accident occurs. Once one of these patients suffers from a GI hemorrhage, in fact, there’s no way to stop it other than just waiting it out, leading to a multitude of serious injuries and fatal accidents.
Many disgruntled individuals who had to suffer one of these, often permanent, injuries claim that they have never been properly warned about the drug’s dangerousness. A storm of more than 15,000 Xarelto lawsuits hit the manufacturers over the course of the whole 2016, and the number still keeps increasing. The vast majority of these cases has been centralized in the Multi-District Litigation number 2592, a large product liability litigation whose first bellwether trial is scheduled to be held on March 2017 in the Eastern District of Louisiana court.
Article by Dr. Claudio Butticè, Pharm.D.
