Pradaxa® Drug Information
Pradaxa (dabigatran etexilate) is a type of blood thinner designed to prevent blood clots.
Approved by the FDA in 2010, Pradaxa is manufactured by Boehringer Ingelheim and is used in patients diagnosed with non-valvular atrial fibrillation to prevent blood clots and stroke. Unfortunately, Pradaxa has been found to cause a number of serious and potentially life-threatening complications.
Pradaxa belongs to a class of drugs known as direct thrombin inhibitors, and is used to prevent stroke and blood clots in patients diagnosed with atrial fibrillation, a heart condition characterized by upper chambers of the heart (atria) that fail to fully contract. This can lead to stagnant blood and the formation of potentially fatal clots.
Worldwide, there have been 260 reports of Pradaxa-related deaths since its release in 2010.
Pradaxa has not yet been issued an FDA recall. However, the FDA did recently issue a Drug Safety Communication and launched a post-market investigation into reports of serious Pradaxa bleeding events. In its review, the FDA states that the “FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa”.