ISMP Ranks Xarelto Most Dangerous Drug in the United States

Thursday, July 28, 2016
Xarelto Anticoagulant

The joint-effort oral anticoagulant Xarelto from Bayer and Johnson & Johnson has seen stellar growth this past year in both sales and approved uses. With nearly 7 million prescriptions now written each year, it dwarfs nearest competitors Eliquis and Pradaxa.

However, Xarelto has been in the news for all the wrong reasons lately. Last fall, a report indicated a major safety study of the drug was tainted due to a malfunctioning test device. Then, reports surfaced that the manufacturers were complicit in keeping the missing data from a major medical journal.


Xarelto Tops FDA Side Effects Reports in U.S.

Now, a leading consumer safety group has ranked Xarelto highest among all domestic drugs for dangerous side effects, based on data from the Food and Drug Administration.

The report came in the June 2016 issue of QuarterWatch, the seasonal journal of the Institute for Safe Medication Practices. The group compiles data from the FDA’s MedWatch, which tracks the agency’s Adverse Event Reporting System (AERS).

For the calendar year 2015, Xarelto (rivaroxaban) accounted for the most reports of serious injury of all drugs monitored in the United States. There were a total of 10,674 reports, of which 8,643 represented Xarelto internal bleeding injuries. More than 4,500 of these cases resulted in the victim being hospitalized, while 1,121 resulted in patient death.

Adverse events may be reported to the FDA by doctors or patients, and are required to be recorded and shared by manufacturers. However, experts estimate that less than half of all drug side effects are disclosed to the FDA.


Oral Anticoagulants Among Tops for Injury

While these numbers are staggering, they are typical in the growing oral anticoagulant market that also includes Pradaxa and Eliquis. Together, this drug class consistently ranks among the most dangerous for the number of reported side effects and deaths.

While all blood thinners have the potential to cause internal bleeding, older versions such as Coumadin gave doctors the option of an antidote injection to stop bleeding in an emergency. The danger comes in the fact that these second-generation drugs claimed to be safer, while not offering the safety net of a bleeding antidote.

Pradaxa has already suffered a similar fate as it lost its market-leading share after facing more than 4,000 lawsuits from patients hospitalized or killed at the hands of internal bleeding. Manufacturer Boeringer Ingelheim eventually paid $650 in settlements in order to avoid a public trial.


Xarelto Lawsuits Growing in Federal Multidistrict Court

As Xarelto reaches this notorious most-dangerous ranking, it also faces a growing number of lawsuits from families affected by internal bleeding.

Cases have been consolidated to the Eastern District Court of Louisiana under U.S. Federal District Judge Eldon Fallon. At present, more than 6,500 cases have been filed. With the first trial scheduled to start in February of 2017, some believe the manufacturers may agree to a Xarelto settlement.

Lawyers are still filing cases for those injured or killed by Xarelto bleeding at no cost. However, the time to take action may be limited.

Check back with DrugNews for more information on blood thinners like Xarelto, as well as the latest recalls, warnings and litigation news.



QuarterWatch Annual Report. Leading Drugs in 4 Monitoring Categories. ISMP. (June 29, 2016). Retrieved from




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