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FDA Warns of Pradaxa Risks

The U.S. Food and Drug Administration recently issued a new safety communication about the safety of Pradaxa (dabigatran etexilate mesylate). Pradaxa is a potentially dangerous pharmaceutical which is sparking a wave of product liability litigation.

Praxada is a blood-thinning medication (anticoagulant) often prescribed to reduce the risk of stroke and blood clots in patients with atrial fibrillation. As with all pharmaceuticals, Praxada can result in serious side effects.

The most common side effect associated with Pradaxa is severe bleeding which may cause death. Individuals who have abnormal bleeding are advised against taking Pradaxa.

The risk for bleeding problems with Pradaxa are increased for patients who are over 75 years old, have stomach ulcers, or kidney problems.

Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies, the FDA noted in its most recent safety communication. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

The announcement was issued after post-market reports of serious bleeding events prompted a federal review of these drugs.