Pradaxa (dabigatran etexilate mesylate) is an anticoagulant drug (blood thinner) prescribed for the treatment of patients suffering from non-valvular atrial fibrillation. It is intended to reduce the risk of blood clot formation and stroke, to which these patients are susceptible.
Pradaxa is manufactured by the German pharmaceutical company Boehringer Ingelheim AG (BI), which first placed the drug on the world market in 2008. It was approved for use in the United States in October 2010 by the FDA. Within its first year, more than 370,00 Pradaxa prescriptions were filled in the U.S. alone.
Early clinical trials of Pradaxa revealed the bleeding risks associated with it, although there is reason to believe the risks may be greater than originally thought.
As with all Direct Thrombin Inhibitors (anticoagulants or blood thinners), Pradaxa is known to increase the risk of internal bleeding, external bleeding and other side effects, including some that are serious or even fatal.
The FDA has issued two drug safety communications regarding Pradaxa. One related to drug storage, and the second, published on December 7, 2011, cautioned that the drug could cause "serious bleeding events." The Agency also indicated it will evaluate ongoing reports of serious bleeding in Pradaxa patients.
Those who are taking Pradaxa should know that FDA approval of a drug does not necessarily mean that it is safe. If this were true, there would be no need for FDA Safety Communications and post-marketing reviews, as has been done with Pradaxa and other pharmaceuticals and medical devices.