Xarelto Linked to Over 20,000 Injuries in 2016: ISMP Report

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As bellwether trials continue in the consolidated Xarelto Multidistrict litigation (“MDL”) pending in the U.S. District Court for the Eastern District of Louisiana, a new drug safety report highlights the dangerous side effects associated with the medication. Xarelto (rivaroxaban) is an anticoagulant drug that has been linked with serious bleeding concerns, including gastrointestinal bleeding and brain hemorrhaging. It was first released on the U.S. market in 2011.

The new report was released by the Institute for Safe Medication Practices (ISMP), a nonprofit organization that educates the healthcare community and consumers about safe medication practices. The ISMP report indicates that blood-thinning drugs like Xarelto were linked to more than 3,000 fatal event reports in 2016. The authors categorized the risks as “unacceptably high.”

Xarelto and Other Anticoagulants Cause Thousands of Bleeding Events

The ISMP publishes a QuarterWatch report each quarter to update doctors and patients on the health risks associated with various medications. This most recent report was released on July 12, 2017, and covers data from 2016, including new data from the fourth quarter of 2016.

Investigators reviewed data from the FDA Adverse Event Reporting System (FAERS) and from a new study by the Centers for Disease Control and Prevention (CDC). They found that anticoagulant drugs, led by Xarelto, accounted for 21,996 reports of serious injuries in the U.S., including 3,018 reported deaths. Most of these injuries were from hemorrhages or uncontrolled bleeding, “making bleeding one of the most frequently reported serious adverse drug effects of all types,” the investigators wrote.

Data from the CDC study, in particular, showed that these drugs accounted for more visits to the emergency room for outpatient adverse effects than any other class of drugs, including opioids (non-abuse visits) and diabetes drugs. Nearly half of these visits required a hospital stay.

Using the CDC data, ISMP estimated that:

6.3 percent of patients taking an anticoagulant for one year will have to go to the emergency room;
over a 10-year period, emergency department visits for anticoagulant adverse drug effects increased more than two-fold; and
the number of drug-related injuries for these drugs may be much higher than believed (the CDC study estimated 228,000 emergency department visits annually—10 times the number of the FARES reports).

ISMP Recommends Second Look at Xarelto Once-a-Day Dose

The ISMP report also showed that oral anticoagulant drugs “rank as the highest priority drug safety problem in 2016.” Out of all the reports of adverse events submitted to FAERS, Xarelto accounted for 15,043 of them (68.4 percent).

Adding to these concerns, Xarelto still doesn’t have an antidote for to stop the bleeding when a patient develops a bleed-related injury. Portola Pharmaceuticals developed an antidote for Xarelto, but in June 2016, the FDA declined to approve it because of manufacturing issues.

Patients taking warfarin can receive vitamin K injections to encourage the blood to clot again. Patients taking Xarelto, however, must simply wait for the drug to clear from their systems, which can make bleeding injuries much more dangerous.