Blood thinners have been on the market for years, mainly in the form of the drug warfarin. Newer anticoagulants, like Xarelto and Pradaxa, are now on the market. These drugs can cause serious side effects and require that the blood’s ability to clot be monitored. There are medical devices out there that check the coagulation levels of the blood in order to prevent dangerous bleeding episodes.
Xarelto is one of these mass marketed drugs. It thins the blood and is intended to prevent blood clots. It is manufactured by Bayer and marketed by Johnson & Johnson. Yet, as the drug continues to be marketed to consumers, news has come out about the dangers associated with the medication. Xarelto has been linked to serious side effects including uncontrollable bleeding.
INRatio is a type of device that monitors the blood’s ability to clot. It is manufactured by Alere, and is used to manage patients taking the drug warfarin. If one takes too little warfarin, they could suffer a stroke, but if they take too much they could bleed to death. However, many of these devices have been recalled due to inaccurate systems and test strips.
Misleading Research
According to a recent article from the New York Times, attorneys for those who were injured by Xarelto are claiming that Bayer and Johnson & Johnson mislead editors of the New England Journal of Medicine regarding Xarelto. Specifically, they claim that critical laboratory data was left out.
The two companies hired the Duke Clinical Research Institute to run a three-year clinical trial. This trial led to Xarelto’s approval by the FDA. However, now, those results are under scrutiny as regulators become aware that the blood-testing device used in the study had malfunctioned. The clinical trial mentioned in the journal, compared the number of strokes and bleeding events experienced by those who were taking Xarelto with those patients using warfarin, an older blood thinning drug. The article then mentions that the concern is that the faulty results from the monitor may have led doctors to give patients the wrong dose of warfarin, which then could have favored use of Xarelto. The faulty evidence is linked to the faulty readings from the INRatio product.
Furthermore, according to the NY Times, in a previous statement, Duke said it had conducted its research separately from the two companies. However, this past fall, Bayer submitted research to the European Medicines Agency that was nearly identical to the approach used by the Duke researchers. Questionable evidence at the least.
At the moment, nearly 3,000 lawsuits regarding Xarelto have been consolidated into a multidistrict litigation. Bellwether trials, a kind of a test trial to see if litigation should move forward, are set to begin early in 2017.
Accuracy of Testing Device
Another article in the NY Times discusses concerns regarding the accuracy of the INRatio product. The article mentions that according to an analysis by the Public Citizen Health research Group, the F.D.A. has received more than 9,000 reports of malfunctions with Alere’s INRatio products, both the monitoring device and the test strips, and more than 1,400 reports of injuries.
The article goes on to mention that the FDA is holding a workshop this March about blood clotting devices. And the INRatio device will certainly be a hot topic. The FDA isn’t singling out just this product, but given the information that has come out about it and its connections to the Xarelto study, it is definitely of importance. Plus it the INRatio is the only device that has come under recent scrutiny for its accuracy, and the workshop was announced after concerns were raised about this product.
Records indicate that problems associated with the INRatio began to become apparent only a few years after it went on the market. However, with the discovery that the INRatio was used in the clinical trial that led to the approval of Xarelto, this device appears even more problematic—not only for those who take warfarin, but for how blood thinning drugs are prescribed to patients. The NY Times article notes that in this trial around 35 percent of the time the INRatio readings differed from a laboratory test result in a way that was “clinically significant.”
Additionally, a recent article from the Wall Street Journal also covers this issue with INRatio monitors. The article discusses an analysis that was prepared before the FDA workshop regarding the devices’ “inaccurate performance,” and that the agency knew of at least 18 deaths liked to faulty readings between 2014 and 2015.
Furthermore, a consumer advocate from the Public Citizen Health Research group felt that one reason for the faulty readings on the devices goes back to the way the FDA cleared them for marketing in the first place. Instead of conducting clinical studies, products can also get FDA approval through a process known as 510(k) pre-market clearance. This is a quicker method where the maker only needs to show that a new product is “substantially equivalent” to another one already on the market. This occurred with the INRatio devices. This has happened with many other medical devices that have gone on to injure consumers, leading many to think this process is problematic.
So, what does this all say? It tells us that there are some hidden dangers with blood thinning drugs and the devices which monitor them, and that we should be aware of this. As always, check with your doctor about anything to do with your medical situation. However, if you have been injured by Xarelto or another blood thinning drug, or by the inaccuracy of the INRatio monitoring device, speak with an experienced attorney today.
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