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According to experts, some Pradaxa patients are exposed to deadly bleeding and stroke risks because Pradaxa has no antidote to reverse its side effects and may cause bleed-out deaths.

What is the problem with Pradaxa?

According to the allegations in the plaintiff lawsuits, Pradaxa has been implicated in more than 500 U.S. deaths over a two-year period. And Boehringer now faces more than 150 lawsuits over allegations that the company sold the drug knowing the medicine could cause bleed-outs. Pradaxa stroke and hemorrhage risk increases in older patients than 75 or those with kidney problems.

Many Pradaxa Lawsuits Filed

Boehringer reported in October that 120 suits had been filed in federal court. Currently there are 154 lawsuits on file in federal court. Suits filed against Boehringer in federal courts across the United States have been consolidated for pretrial work up in East St. Louis, Illinois. About a dozen additional Pradaxa claims are pending in state courts.

Pradaxa History

The U.S. Food and Drug Administration approved Pradaxa in 2010 as an alternative to Coumadin,for preventing strokes caused by blood clots. Coumadin has been the mainstay for oral anticoagulant therapy for the past 50 plus years.

Atrial Fibrillation, Embolic Stroke and Anticoagulant Therapy

Atrial fibrillation is an abnormal heart rhythm that affects 2.2 million Americans. Atrial fibrillation increases the risk of blood clots forming in the heart, which can break off and cause a stroke, this is known as an embolic stroke. Doctors have relied on aspirin and Coumadin to help prevent strokes by thinning out the blood, making blood clot formation less likely.

FDA Adverse Reports

According to the FDA, there are reports of 542 deaths and 3,781 side-effect incidents associated with Pradaxa in 2011.
Pradaxa has more reports of injury or death than any of the 800 medicines monitored by the Institute of Safe Medication Practices, a Pennsylvania-based nonprofit group that studies medication use. Boehringer acknowledged in November 2011 that Pradaxa had been linked to 260 deaths worldwide.

The case is In re Pradaxa Products Liability Litigation, 12-MD-2385, U.S. District Court, Southern District of Illinois (East St. Louis).

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FDA: Pradaxa Bleeding and Hemorrhage Report Posted November 03, 2012

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