Xarelto Tied to 15,000+ Adverse Events in 2016

Published on July 14, 2017 by Laurie Villanueva

Blood-thinning medications were implicated in more than 21,000 serious injuries last year, including more than 3,000 deaths.  According to the Institute for Safe Medication Practices’ (ISMP) latest QuarterWatch Report, serious side effects associated with Xarelto far outpaced other drugs in this class.

The ISMP’s report looked at “notable signals of significant drug risk” as reflected in the U.S. Food & Drug Administration’s (FDA) adverse events database. For the 2016 calendar year, the agency received 21,996 reports associated with five blood-thinning drugs: Xarelto, Eliquis, Pradaxa, Savaysa and warfarin. The total included 3,018 patient deaths.

Xarelto alone accounted for 15,043 adverse events. It was followed by Eliquis (3,148), Pradaxa (1,944), warfarin (1,753) and Savaysa (108). The vast majority of the reports involved serious internal bleeding events, including 8,495 reports of gastrointestinal bleeding and 1,019 reports of cerebral hemorrhage. Another 790 cases of possible cerebral hemorrhage were reported.

Steps Needed to Reduce Blood Thinner Risks

“From the outset, long-term use of oral anticoagulants is a dangerous balance between a clearly demonstrated benefit in preventing ischemic strokes against a high risk of bleeding, including a smaller but still substantially increased risk of hemorrhagic strokes,” the report notes. “Many health professionals were willing to risk causing more hemorrhages that could be treated in the interests of preventing disabling, life-changing ischemic strokes. But the need is great to reduce the risks of this class of drugs.”

The ISMP recommended seven steps for reducing the risk associated with Xarelto and other blood-thinning medications:

  • Ensure wide availability of antidotes to reverse internal bleeding that sometimes occurs with blood-thinning medications. Hemorrhaging caused by warfarin can be reversed via the administration of vitamin K, while a reversal agent was recently approved for Pradaxa. However, there is currently no approved antidote to reverse internal bleeding caused by Xarelto, Eliquis or Savaysa.
  • Establish guidelines for combined therapy with anti-platelet agents (aspirin, clopidogrel, prasugrel) and oral anticoagulants, especially in older patients.
  • Re-evaluate the suitability of Xarelto’s once-a-day dosing scheme compared to similar agents with a dosing scheme better matched to the drug half-life.
  • Provide therapeutic ranges for Pradaxa to identify patients with suboptimal and excess anticoagulant effects.
  • Take steps to ensure that the ease-of-use of the newer agents does not lead to overuse.

Xarelto Litigation

Xarelto obtained FDA approval in October 2011. Like other novel anticoagulants, it was marketed as an improvement on warfarin, as marketing materials touted Xarelto’s once-daily dose regimen and promised patients they would not be subjected to a regular blood-testing protocol.

Court documents indicate that more than 17,000 Xarelto lawsuits are currently pending in the U.S. District Court, Eastern District of Louisiana, where all federal claims involving the drug’s alleged bleeding side effects have been centralized for coordinated pretrial proceedings. Among other things, plaintiffs question the medication’s purported superiority over decades-old warfarin, pointing to the lack of a reversal agent for Xarelto bleeding. They further contend that patients using Xarelto would benefit from regular blood monitoring and question the efficacy of its one-size-fits-all, once-daily dosing scheme.

Just two Xarelto lawsuits have gone to trial in Louisiana, both of which ended with defense verdicts.  A third case is slated to go before a jury on August 7th in the U.S. District Court, Southern District of Mississippi.

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