ISMP Flags Xarelto Side Effects Reports
A new analysis indicates that reports of Xarelto side effects, including those involving uncontrollable internal bleeding, continued to mount in 2015. According to the Institute for Safe Medication Practices (ISMP), the blood thinner accounted for 10,674 reports of fatal, disabling, and serious injury in the U.S., more than any other drug the group monitors.
According to the ISMP’s latest QuarterWatch report, an analysis of the U.S. Food & Drug Administration (FDA) adverse event database revealed 1,121 deaths linked to Xarelto. At least 8,643 reports detailed cases of Xarelto bleeding or hemorrhaging, and 1,611 were attributed to an embolic-thrombotic or blood clot event.
“For comparison, the median number of reports per drug was 7 cases, with 25% of drugs accounting for 4 or fewer serious cases in 2015, and 25% accounting for 103 cases or more,” the ISMP said.
Though these events were reported to the FDA in 2015, the group did note that 36% of the incidents had actually occurred in previous years. However, this would also mean that Xarelto adverse events were under reported during those years.
Xarelto and Internal Bleeding
Xarelto is a new generation blood thinner that was only launched in 2011. While the drug’s manufacturers tout it as an improvement over warfarin – a decades-old blood thinner sold under the brand-name Coumidin—RXInjuryHelp.com points out that there is currently no approved antidote to reverse internal bleeding that sometimes occurs among Xarelto patients. While warfarin can cause similar bleeding, the complication can be reversed via the administration of vitamin K.
Xarelto is currently the subject of thousands of personal injury lawsuit filed on behalf of patients who allegedly suffered life-threating internal bleeding due to their use of the medication. Plaintiffs claim that the drug’s makers engaged in misleading marketing in order to drive Xarelto sales, and they further allege that the companies failed to properly warn patients and doctors about its potential risks. The complaints also assert that those using Xarelto would benefit from a regular blood testing regimen to assure appropriate dosage – something that is required of warfarin patients – despite the manufacturers’ promises that such monitoring is not necessary.
Federally filed Xarelto lawsuits have been centralized in a multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. That proceeding is scheduled to begin a series of bellwether trials in February 2017, the outcomes of which could provide clues as to jury decisions in similar Xarelto cases. Forty lawsuits have already been designated as potential bellwether trial candidates, and discovery in those cases is now moving forward.
Free Xarelto Legal Reviews Now Available
The nationwide law firm of Bernstein Liebhard LLP is currently representing a number of Xarelto lawsuit plaintiffs. If you are interested in filing a claim of your own, please call 877-779-1414 to discuss the matter with a member of our legal team.