Study investigates bleeding deaths associated with blood thinner Pradaxa

The death of Bob Smith* was a surprise to doctors. The 83-year old man was evaluated for what appeared to be a rather routine fall, and by all accounts he seemed fine. He was fully alert and oriented and could respond to verbal commands. CT scans taken when he arrived at the hospital revealed small, superficial areas of hemorrhage in his brain, but two hours later, another round of scans showed extensive progression of brain hemorrhaging. Efforts to stop the bleeding were fruitless. The elderly man fell into a deep coma and died soon after.

What happened to Bob was not an isolated case. The man had been taking Pradaxa, a drug recently approved by the Food and Drug Administration (FDA) to prevent strokes in patients who also had a dangerous irregular heartbeat known as atrial fibrillation. The drug, known chemically as dabigatran, is a new class of oral medications called direct thrombin inhibitors. There are currently no effective reversal agents to counter the affects of Pradaxa. A study published in the Journal of Neurosurgery suggests that bleeding complications from Pradaxa are largely irreversible.

According to researchers, dialysis might remove 35 to 60 percent of Pradaxa from the bloodstream in two to three hours but that treatment may not be considered unless medical staff was familiar with the drug and took quick action.

There were already concerns about Pradaxa. In December, the FDA announced it was evaluating cases of bleeding associated with the blood clot preventer, but advised patients to continue taking it until a formal decision was made. Meanwhile, foreign drug regulators have added stronger warnings about the drug. Since Pradaxa was approved, there have been more than 260 deaths associated with the blood thinner.

Source: Fox News
* Patient’s name has been changed

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