January 4, 2012
Pradaxa Side Effects: Stroke drug linked to serious and even fatal injuries
Following a November 2011 warning issued by the European Medicines Agency (EMA), the Food and Drug Administration (FDA) decided to reevaluate the safety of Pradaxa®. The EMA reported 256 cases of serious and even fatal bleeding complications associated with Pradaxa.
Pradaxa, generically known as dabigatran etexilate mesylate, is blood-thinning (anticoagulant) drug prescribed to reduce the risk of blood clots and stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.
According to the FDA, bleeding that may be serious or fatal is a known complication of all blood-thinning therapies, but the organization is working with Pradaxa manufacturer Boehringer Ingelheim to review post-market reports of bleeding to determine whether they are higher than should be expected based on observations from the clinical trial that supported the drug's approval in 2010.
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