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Faulty Blood Testing Devices to Be Withdrawn from Market

The manufacturer of blood testing devices which POGO reported to have potentially fatal flaws has announced that it is taking the machines off the market at the request of the Food and Drug Administration (FDA).

Alere Inc., based in Massachusetts, said it is withdrawing the INRatio and INRatio2 devices, which are used to monitor patients on the blood thinner warfarin to make sure their blood isn’t dangerously thick or thin.

The action comes more than a year and a half after the FDA website said the devices can deliver false readings, which may “cause severe or life-threatening injuries, including death.”

It also comes several years after INRatio devices played a crucial role in a major clinical trial.

Last year, POGO reported that INRatio devices were used to monitor patients and help doctors calibrate warfarin dosing in a clinical trial that compared the widely advertised new-generation blood thinner Xarelto to warfarin, which has been in use since the 1950s. On the basis of that trial, the FDA in 2011 approved Xarelto for patients who suffer from atrial fibrillation, a heart condition that can cause blood clots and strokes.

More recently, the FDA has been studying whether the faulty devices affected the trial.

“Our analyses so far indicate that effects on strokes or bleeding, including bleeding in the head, were minimal,” FDA spokeswoman Deborah Kotz said Tuesday in a written response to questions from POGO. “These effects were very unlikely to have altered our determination in 2011 that Xarelto was a safe and effective alternative to warfarin in patients with atrial fibrillation.”

SEE RELATED story: [FDA: Faulty Devices Had “Minimal” Impact on Xarelto Study]

The FDA’s European counterpart in February completed a review of the trial and found widespread anomalies in blood test readings. However, the European regulator reported that those inconsistencies did not change its assessment of Xarelto’s risks and benefits.

The INRatio devices, which analyze drops of blood applied to test strips, can be used in doctors’ offices and patients’ homes to measure clotting rates.

It is unclear why it took Alere and the FDA so long to remove the devices from the market.

As early as 2005 and 2006, problems with INRatio devices were the subject of FDA warning letters.

In response to questions from POGO yesterday, the FDA’s Kotz said Alere “worked on fixing” the issues raised in the warning letters.

Though the 2014 warning posted by the FDA was titled a “Recall,” it was more of a non-recall recall, because it allowed the machines to remain in circulation.

Alere spokeswoman Jackie Lustig told POGO last year that the company was “working diligently to develop a software upgrade” to “address the potential for inaccuracies.”

In its announcement Monday, Alere said it was confident that “software enhancements” it submitted to the FDA at the end of last year addressed the problem. However, the FDA disagreed.

Alere said it was acting voluntarily, but it also made clear that it was under pressure from the FDA.

The agency “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,” Alere said in a news release.

Apparently, the company and the FDA have not yet decided how to do that.

“Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients” to other testing methods, the company said.

Alere expects to incur $70 million to $90 million of charges this year in connection with the INRatio withdrawal, the company said in a filing with the Securities and Exchange Commission.

Defying the FDA’s request could have greatly increased the company’s liability for any subsequent harm to patients, said Sidney M. Wolfe, a physician and consumer advocate at Public Citizen’s Health Research Group.

At an all-day public meeting or “workshop” in March devoted to monitoring clotting rates in warfarin patients, FDA officials, device makers and others made clear that problems with blood testing are far from limited to Alere’s products.

The FDA has received a large number of reports of “malfunctions, serious adverse events, and patient deaths, and this has led the agency to reassess the safety of these devices,” Lea Carrington, an FDA division director, said at the March meeting, referring to no particular brand of portable testing device.

POGO asked the FDA spokeswoman what else the FDA has done about those problems since March.

“The FDA plans to work on issuing guidance and revamping international studies based on input received at the workshop,” Kotz responded.