The FDA has recently noted that there appears to be a trend of serious adverse events among those taking anticoagulants, which may be linked to faulty performance of blood clotting monitors. Senior FDA official Dr. Alberto Gutierrez recognizes this trend, but explains how it is difficult to measure how often these deaths are directly due to device malfunctions. This is because many people taking drugs such as Warfarin are prone to fatal events such as strokes and irregular bleeding. All factors considered, the FDA estimates eighteen deaths in the past two years were linked to erroneous readings. One theory, proposed by Sidney M. Wolfe, Senior Advisor to Public Citizen Health Research Group, suggests that the faulty devices can be attributed to the lack of proper FDA approval process. He continued by explaining how the FDA pushes these products through quickly because they only require that companies prove their device are substantially equivalent to one currently on the market.
Research on this topic has only scratched the surface, and industry professionals such as Wolfe believe that the FDA should continue their investigation into such devices.
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