Since Pradaxa was approved by the U.S. Food and Drug Administration (FDA) in 2010, hundreds of patients have reportedly suffered Pradaxa side effects. By the end of 2011 alone, the agency logged 3,781 adverse event reports stemming from Pradaxa, as well as 500 deaths tied to the Boehringer-Ingelheim-manufactured blood thinner.
The following Pradaxa side effects have been listed by the FDA:
If you are taking Pradaxa, which is prescribed to reduce the risk of a stroke in patients who suffer from non-valvular atrial fibrillation, it is noteworthy to add that that these internal bleeding side effects may prove to be life-threatening as there is no known antidote to reverse them.
Recent studies have also shown the potential for Pradaxa problems to develop in patients is very likely. In a recent report dated September 24, 2012, researchers at the University of Pecs in Hungary found that people who used Pradaxa were three times more likely to develop excessive internal bleeding than those who did not.
Pradaxa side effects have prompted regulatory health agencies in U.S, Australia, Japan and Europe to issue advisories for using the blood thinner. In fact, Health Canada and the U.S. Food and Drug Administration (FDA) both issued public health alerts this past December warning the public about the heightened danger of Pradaxa use for patients who have undergone mechanical artificial heart valve replacement procedures. According to the agency, this demographic may be more likely to experience heart attacks, blood clots, and strokes after taking the drug. Pradaxa’s labeling will now be updated in both countries to say doctors should not prescribe the blood thinner to these patients.
In the U.S., all health care providers will also be receiving “Dear Doctor Letters” informing them of this change.
If you suffered life-threatening internal bleeding or other Pradaxa side effects, call a lawyer at Bernstein Liebhard LLP at .