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Pradaxa Bleeding Reports to FDA Increase

Filed April 9th, 2012 Laurie

The popular blood thinner Pradaxa is the subject of six wrongful death lawsuits, but a new report by the Food and Drug Administration says the drug might be responsible for an additional 117 deaths during the second quarter of 2011.

The Institute for Safe Medication Practices published their new quarterly report earlier this week on adverse event reports between April and June 2011. The drug is associated with more adverse event reports than any other regularly monitored medication. There have been 856 reports of serious, disabling, or fatal injury in the second quarter of 2011. That number included 117 deaths, and 511 bleeding events.

Pradaxa, manufactured by Boehringer Ingelheim, was released to the market as a superior alternative to the drug Coumadin for the prevention of strokes in patients who have atrial fibrillation. It is the first approved from a class of drugs, known as “direct thrombin inhibitors,” that blocks the enzyme pathway that causes blood to clot. There is no antidote to Pradaxa, however, and bleeding side effects can only be treated with dialysis.

An increasing number of patients in the United States are pursuing lawsuits against Boehringer Ingelheim, accusing them of failing to adequately research Pradaxa or warn the public about the serious and potentially life-threatening side effects

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