As parties prepare for the second Xarelto bellwether trial in the Xarelto Multidistrict Litigation (MDL)in the Eastern District of Louisiana, the Institute of Safe Medication Practices (ISMP) has released their QuarterWatch report for the third quarter of 2016.
Among the institute’s findings is an increase in aspirin-related bleeding events, which they believe is actually related to the use of Xarelto with aspirin.
ISMP Blames High Number of Aspirin Events on Drugs Like Xarelto
The ISMP noticed an “unexpectedly large number” of serious adverse drug events reported about aspirin. It was the primary suspect drug in over 2,000 cases, including 169 patient deaths and over 1,100 cases of gastrointestinal bleeding. Aspirin was also the cause of more serious injuries to U.S. patients 75 years and older than any other drug.
When the researchers looked more closely into the cases, however, they found that aspirin was often used with other drugs that inhibit blood clots, including Xarelto, Eliquis, and warfarin (Coumadin). They noted that combining drugs that have the ability to reduce blood clotting creates a high risk of bleeding. Previous studies of Pradaxa, a newer-generation anticoagulant, showed that combining the drug with one like aspirin doubled the risk of severe bleeding.
Other studies have reported that adding aspirin to Eliquis also increases the risk of bleeding two-to four-fold. The ISMP noted that long-term administration of drugs like Xarelto and Eliquis causes bleeding in 10-15 percent of patients per year, and life-threatening hemorrhages in two to four percent of patients.
Xarelto (rivaroxaban) is a new-generation anticoagulant (blood thinning drug) used to help prevent stroke in people with non-valvular atrial fibrillation and to prevent blood clots in those with deep vein thrombosis (DVT). Aspirin is a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain. Both have blood-thinning properties.
The ISMP warned that combining anticoagulant drugs like Xarelto with aspirin can be especially dangerous due to the bleeding risk and suggested that the FDA sponsor a “reanalysis” of clinical trial data on blood thinning drugs “with a goal of identifying appropriate use of dual therapy with aspirin and other antiplatelet agents with anticoagulants.”
Over 18,000 Xarelto Lawsuits Pending
Patients who took Xarelto and then suffered serious injuries like gastrointestinal bleeding have filed lawsuits against manufacturers Janssen Pharmaceuticals and Bayer AG in an attempt to recover damages. Over 18,000 such lawsuits are currently pending in the Xarelto MDL in the Eastern District of Louisiana.
The first Xarelto MDL bellwether trial started in late April and involved a plaintiff who took the drug and a month later, was hospitalized with gastrointestinal bleeding and required multiple blood transfusions. The jury ultimately found in favor of the Defendants following a week-long trial.
The second Xarelto MDL bellwether trial starts at the end of May 2017.