Xarelto Complications and Injuries Stand Out Among FDA Adverse Event Reports Last Year

Austin Kirk

By Austin Kirk
Posted July 6, 2016

UPDATE: Following a $775 million global settlement announced in March 2019, Saiontz & Kirk, P.A. is no longer reviewing new Xarelto cases. This page is provided for informational purposes only.

As thousands of Xarelto injury lawsuits continue to move forward through the court system, a new report highlights the extent of severe problems and bleeding complications that have been linked to this controversial drug.

The Institute for Safe Medication Practices (ISMP) released a report (PDF) this week, indicating that more than 10,000 serious adverse event reports were submitted to the FDA in 2015, including at least 1,121 deaths among users of the anticoagulant that has been aggressively marketed as a superior replacement for warfarin.

The independent group monitors all adverse events submitted to the FDA, and summarized the findings in an annual report. Xarelto complications and injuries stood out, as the number linked to this one drug exceed those associated with all other medications monitored by the ISMP.

The Xarelto lawyers at Saiontz & Kirk, P.A. are pursuing injury claims for individuals and families who have experienced complications similar to many of those reported, including:

  • Uncontrollable Bleeding
  • Hemorrhagic Stroke
  • Pulmonary Embolism
  • Wrongful Death

Xarelto Adverse Events

According to the ISMP report, there were 10,674 fatal, serious or disabling adverse event reports submitted to the FDA involving complications with Xarelto in 2015. This included 1,121 deaths on Xarelto.

By comparison, the median number of reports for the 1,395 drugs currently on the market was seven, and about 25% had four or fewer serious complications reported in 2015, while only 25% of all drugs had over 103 serious adverse event reports.

The vast majority of Xarelto complications submitted to the FDA in 2015 involved hemorrhaging, which accounted for more than 80%. The next highest category was injuries related to blood clots or embolism, which consisted of about 11% of the reports.

The number of Xarelto adverse events is probably much higher, as experts estimating that the FDA only receives reports for about 10% of drug adverse events that actually occur. In addition, many of the Xarelto reports submitted last year occurred in prior years, suggesting that many individuals and families are just now learning about the link between Xarelto and bleeding events.

While all anticoagulants carry a risk of bleeds, Xarelto side effects appear to increase of severe and life-threatening complications, as the drug maker failed to adequately disclose the lack of a safe and effective reversal agent and withheld warnings from consumers and the medical community.

Xarelto Injury Lawsuits

The product liability lawyers at Saiontz & Kirk, P.A., are reviewing lawsuits for individuals nationwide who have suffered Xarelto internal bleeding problems or who have lost loved ones due to Xarelto complications.

All cases are pursued by our law firm under a contingency fee agreement, which means that there are no out-of-pocket costs to hire a lawyer and we receive no attorney fees or expenses unless a Xarelto settlement or other recovery is obtained.

UPDATE: Following a $775 million global settlement announced in March 2019, Saiontz & Kirk, P.A. is no longer reviewing new Xarelto cases. This page is provided for informational purposes only.

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