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Alere to withdraw monitoring system used in ROCKET AF from US market
Alere Inc. announced that after consultation with the FDA, it has decided to withdraw two of its point-of-care INR monitoring systems from the U.S. market.
“Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anticoagulation monitoring in the least disruptive manner possible,” the company stated in a press release.
Alere had announced in December 2014 that two of its monitoring systems (INRatio and INRatio 2) should not be used by patients with characteristics such as abnormal hematocrit levels; raised fibrinogen levels and related conditions; and bleeding or bruising. Shortly afterward, the company reported the concerns to the FDA and began an investigation.
The announcement generated controversy in part because one of the systems (INRatio) had been used in ROCKET AF, a U.S. pivotal trial comparing the novel oral anticoagulant rivaroxaban (Xarelto, Janssen Pharmaceuticals) with warfarin in patients with nonvalvular atrial fibrillation at high risk for stroke. Patients taking warfarin must have their INR level monitored frequently.
Post hoc analyses published in a letter to The New England Journal of Medicine determined that use of the Alere device did not affect the safety and efficacy outcomes of ROCKET AF, as the outcomes of patients with a recall condition were consistent with those of the overall cohort, and the outcomes of patients with no recall condition were consistent with those of the overall cohort. “This finding does not support the hypothesis that device malfunction led to an increased risk of bleeding in the warfarin group of the trial,” the researchers concluded.
Alere stated in the release that it spent the past 2 years developing “software enhancements to address the potential, in certain cases, of the system to deliver a result that differs from another measurement method.”
However, the company stated, “Although Alere is confident that the enhancements it developed and submitted to the FDA at the end of 2015 effectively address this issue, the FDA notified the company that it believes the company’s studies do not adequately demonstrate the effectiveness of the software modification and advised Alere to submit a proposed plan to voluntarily remove the INRatio device from the market.”
Patients should “speak with their health care providers prior to making any changes to their current PT/INR monitoring practices,” the company stated in the release.