Xarelto, a new generation blood thinner, is currently under closer examination for its safety following numerous reports of serious side effects.

Upon its release to the market, experts claimed that Xarelto was superior to Coumadin (warfarin), the previous gold-standard of treatment for use as an anticoagulant. Manufacturers asserted the new drug’s advantages included its apparent safety and the ease of using less frequent blood monitoring as compared to the former drug option.

In a recent editorial in the Journal of the American Medical Association (JAMA), Dr. J Robert Powell questioned the safety of Xarelto and other new direct-acting oral anticoagualants (DAOCs), including Eliquis and Pradaxa. He noted that the current marketing of the newer drugs that highlights their safety and ease of use could actually be counterproductive in its efforts by potentially undermining patient safety.

Drug trials for newer generation blood thinners like Xarelto have been tainted with controversy. Pradaxa was the first of the DOACs to be approved after the RE-LY clinical trial. Some grave concerns emerged following the trial including the questioning of the trial’s accuracy, removed data suggesting that frequent monitoring could have prevented the risk of fatal bleeding complications, and the missing reports of bleeding events the manufacturer Boehringer Ingelheim Pharmaceuticals admitted to leaving out of the initial results.

According to Dr. Powell, information provided by Boehringer Ingelheim Pharmaceuticals after their initial clinical trial report suggested that dose individualization was just as effective for patients and could potentially lessen the adverse bleeding events and enhance safety for patients. Dr. Powell also advocated for more close blood monitoring of patients as a step in the right direction for improved patient outcome and protection from adverse drug effects.

Xarelto Internal Bleeding

Xarelto and its predecessor warfarin are used as blood thinning agents to prevent strokes caused by atrial fibrillation.

The most severe side effect reported from Xarelto and new-generation blood thinners is severe internal bleeding. While internal bleeding was also a concern for the older anticoagulant warfarin, there was an antidote to the blood-thinning effects of the drug.

Physicians are able to administer intravenous vitamin K along with fresh frozen plasma to stabilize warfarin-induced bleeding. Xarelto, however, has no effective reversal agent, so there is no way to quickly and safely stop the bleeding once it has started. Like Xarelto, the other new drugs Pradaxa and Eliquis also lack an effective antidote to bleeding complications as a result of their use.

Ongoing Safety Concerns for Xarelto and New Blood Thinners

Pradaxa was the first new anticoagulant to be approved for use as an alternative to warfarin, followed by Xarelto and Eliquis. In its first year of use, Pradaxa gained notoriety as a pharmaceutical laden with reports to the FDA regarding adverse effects. Affected consumers believed there were inadequate safety warnings on the new pharmaceutical’s lack of a reversal agent. Xarelto lawsuits regarding drug safety were subsequently filed, with manufacturer Boehringer Ingelheim Pharmaceuticals paying out $650 million in Xarelto lawsuit settlements in 2014.

While physicians and patients began questioning Pradaxa’s safety, Xarelto began to be prescribed more often in its place, and the drug exceeded sales of Pradaxa in 2013. However, with more widespread use of Xarelto came more adverse reactions reported on its use as well. Currently, Xarelto lawsuits are being filed against the drug’s manufacturers for also failing to have inadequate safety warnings.