According to FDA Warnings, Pradaxa increases a patient's risk of severe internal bleeding more than other blood thinners prescribed in the United States. Tracking adverse events through the federal reporting system, regulators found that Pradaxa bleeding deaths are far more common than anticipated.
Pradaxa (dabigatran etexilate mesylate) is a direct thrombin inhibiting blood thinner, which prevents stroke by keeping the blood from clotting. Direct thrombin inhibiting blood thinners are an important class of medications which help to prevent embolic stroke in persons who suffer from atrial fibrillation. Stroke is a very real danger for these patients, and Pradaxa is effective at reducing the threat. However, the question that must be asked of Pradaxa is whether its benefits outweigh its risks.
Inherent with a blood thinner is an increased risk of bleeding events, but researchers say Pradaxa's risk is higher than other similar drugs, and higher than had been anticipated by federal regulators when Pradaxa was first approved for use in the United States.
For decades, warfarin was the only drug available for this purpose. Warfarin was effective yet inconvenient, requiring regular blood testing and dosage adjustments. When alternatives billed as more convenient to patients were released in the United States, the first being Pradaxa, the drugs were embraced by physicians and patients.
Now we know that while simpler in some ways, Pradaxa puts patients in grave risk of life threatening and unstoppable internal bleeding. The threat of serious bleeding has left many doctors wondering if Pradaxa should be prescribed at all, given that there are safer alternatives available.
Adverse events reports show that Pradaxa bleeding deaths are more common than initial safety testing had indicated they would be. While the drug is being investigated by the FDA, many patients and family members harmed by the drug have filed Pradaxa lawsuits.
Pradaxa bleeding deaths are largely blamed on the fact that researchers have yet to find a reliable antidote once bleeding begins. In comparison, bleeding caused by warfarin can be quickly stopped with a simple Vitamin K injection. There is no such substance that can reverse the effects of Pradaxa. Pradaxa bleeding deaths have occurred in hospitals while patients were under expert care.
In January of 2012, the FDA required Boehringer Ingleheim to expand the Pradaxa bleeding warning found on the drug's packaging. The label now reads: "Pradaxa increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding". Some physicians have called for a Black Box warning to caution patients of the risk of fatality, yet this step has not been taken in the United States.
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In 2011, the FDA Pradaxa warning stated that severe internal bleeding and Pradaxa bleeding deaths were far more common than anticipated. In 2012, an internal bleeding warning was added to the Pradaxa label. Read detailed information about the FDA Pradaxa warnings here.
Persons and the family members of persons who have suffered from severe and life-threatening internal bleeding events from Pradaxa, may qualify to file a Pradaxa side effects lawsuit. Contact these attorneys to learn about contingency representation â€“ you'll never pay a legal fee unless they win on your behalf.