Xarelto, Eliquis Interactions With Aspirin May Have Led To Deadly Side Effects: ISMP

Increased reports of bleeding problems with aspirin use may actually be linked to the side effects of Xarelto, Eliquis and other blood thinners, according to the findings of a new drug safety report. 

In the most recent edition of the Institute of Safe Medication Practices (ISMP) QuarterWatch report (PDF), which evaluated all FDA adverse event reports submitted over the 12 months ending on September 30, 2016, researchers noticed an increased incidence of reports involving aspirin-related bleeding events. However, the group suggests that the issues may actually be caused by patients combining aspirin with Xarelto and Eliquis, which are anticoagulants commonly linked to bleeding problems.

“Our interest was spurred when an unexpectedly large number of serious adverse drug events in 2016 Q3 were attributed to the ubiquitous and invaluable drug aspirin,” the ISMP report states. “For the most recent quarter, aspirin was the primary suspect drug in 2,134 reported cases, including 169 patient deaths and 1,137 gastrointestinal hemorrhages. In another ranking of the new quarter of data, aspirin accounted for more serious injuries to U.S. patients 75 years and older than any other therapeutic drug.”

The ISMP researchers thought the increase was some kind of anomaly, given aspirin’s long use and track record, so they dug further into the numbers, finding that the patients who were reporting injuries were also combining aspirin with Xarelto, Eliquis, and warfarin, as well as other anticoagulants, such as Pradaxa and Lovenox.

Researchers found that 87.4% of the case reports indicated a bleeding event, and noted that previous studies showed that using Xarelto and aspirin at the same time increased the risk of bleeding two- to four-fold. Long-term use of similar anticoagulants and aspirin caused bleeding problems in 10% to 15% of patients per year, and life-threatening bleeding events in 2% to 4%.

Xarelto (rivaroxoaban), Eliquis (apixaban) and Praxaxa (dabigatran) are novel oral anticoagulants introduced in recent years as superior alternatives to warfarin, which has been the go-to anticoagulation treatment to prevent blood clots for decades.

While the drugs have been aggressively promoted as easier to use, claiming that they do not require the same close monitoring to maintain appropriate dose, concerns have emerged about the safety of the medications, as thousands of reports suggest that users may experience severe and uncontrollable bleeding problems, since the drugs did not have an approved reversal agent at the time they were introduced.

Unlike warfarin, where the blood thinning effects of the drug can be reversed quickly with vitamin K and fresh frozen plasma if bleeding problems develop, no safe and effective antidote was available for Xarelto, Eliquis or Pradaxa when they were introduced.

Due to the drug makers’ failure to warn about the lack of an effective reversal agent, tens of thousands of Xarelto lawsuits, Pradaxa lawsuits and Eliquis lawsuits have been filed in courts nationwide, each involving similar allegations that the medical community was not adequately warned about the bleeding risks.