A lawsuit filed June 19 in St. Louis Circuit Court alleges that Boehringer Ingelheim Pharmaceuticals Inc. and Boehringer Ingelheim International GMBH failed to warn medical professionals and patients about the risks associated with the use of the anticoagulant Pradaxa, according to a St. Louis Record report.
The U.S. Food and Drug Administration (FDA) approved the blood thinner Pradaxa in October 2010 to reduce the risk of stroke and systematic embolism in patients with non-valvular atrial fibrillation. But according to the case, the harmful side effects of the medication were never disclosed to the patients and their physicians, leading to serious injuries and even death in some cases.
What is Pradaxa?
Anticoagulants like Pradaxa belong to the stroke category of medications, which were approved by the U.S. Food and Drug Administration (FDA) to:
Pradaxa is part of a class of drugs known as new generation oral anticoagulants that have been approved over the past several years to give patients a wider range of options to treat and prevent thromboembolic disorders in adults.
How do Blood Thinners Work?
Blood thinners, or anticoagulants, work by interrupting the process involved in the formation of blood clots. Although they’re sometimes called blood thinners, these medications don’t actually make the blood thinner. Rather, anticoagulants prevent blood clots from forming by preventing red blood cells, platelets, fibrin, and white blood cells from sticking together to form a clot.
Bleeding is a complication common to all anticoagulants, and although dangerous bleeding is relatively rare, it occurs in approximately 1.5 percent of Pradaxa patients every year. In October 2015, the FDA granted approval of Praxbind (idarucizumab) as an antidote for the anticoagulant Pradaxa for use when reversal of the blood thinner is needed for emergency surgery or in life-threatening or uncontrolled bleeding events.