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.
Read the FDA Pradaxa Safety Announcement.
We are reviewing potential Pradaxa lawsuits. If you or someone you love has experienced Pradaxa side effects involving serious bleeding complications, please contact Jon L. Gelman via email or by calling 1.973.696.7900.