Pradaxa also has other problems in addition to the irreversibility, the letter said, namely that there are no readily available tests to assess how well it's working or not working.
"You can't really check the labs. There's no easy, cheap, readily available lab test," Cotton noted.
The information provided in the letter, said Dr. Lisandro Irizarry, chair of emergency medicine at the Brooklyn Hospital Center in New York City, is "incredibly useful and incredibly timely."
"Although this medication provides enhanced quality of life, it does have a significant impact on how we manage patients because there's no way to reverse it and no way to measure how thin the blood is," he said.
Cotton and his co-authors urged the U.S. Food and Drug Administration (FDA) to support more trials to assess the potentially wide-ranging effects of the drug.
"We absolutely understand that it's a lot better for patients from a convenience standpoint . . . but when something goes wrong, it can go wrong very badly," Cotton said.
In a statement, Pradaxa's maker, Boehringer Ingelheim, confirmed that, "At this time, there is no reversal agent available" for the blood thinner. The company says that dialysis can lead to "the removal of about 60 percent of the drug over two to three hours; however, data supporting this approach are limited."
In the meantime, "Patient safety is our top priority and we frequently communicate with the FDA and regulatory agencies around the world to ensure they have the most up-to-date information regarding the safety profile of Pradaxa," the company said. "All treatment decisions should be made on an individual basis between patie
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