The blood thinner Pradaxa (dabigatran), manufactured by Boehringer Ingelheim, has long been associated with increased risks of excessive, sometimes uncontrollable, bleeding events.
Pradaxa was cleared by the U.S. Food and Drug Administration (FDA) FDA in 2010 and is typically prescribed to patients diagnosed with atrial fibrillation. Patients diagnosed with atrial fibrillation are at greater risk for blood clot-related injuries, including stroke. Pradaxa is meant to reduce risks for stroke and systemic embolism.
Atrial fibrillation causes alterations in the heart’s rhythm. This physical defect may allow clots to form within the heart, which may then travel to the brain’s blood vessels, which may cause a stroke. Anticoagulants, including Pradaxa, help in reducing the risk of stroke in patients diagnosed with atrial fibrillation.
Unfortunately, drugs such as Pradaxa may lead to difficult-to-control excessive bleeding. In fact hundreds of cases of hemorrhages and gastrointestinal bleeds have been reported in patients treated with Pradaxa. In some cases, these bleeding events have led to death.
One clinical study, known as the RE-LY trial, compared the effects of Pradaxa to those of warfarin. Warfarin, also known by the brand name Coumadin, is a traditional blood thinner that may lead to bleeds, but does have a treatment plan in such an event. Warfarin treatment does require ongoing blood testing and potential dosage changes.
Researchers in the RE-LY trial discovered that Pradaxa patients experienced a greater rate of gastrointestinal bleeds, as well as a similar rate of major bleeds when compared to individuals treated with warfarin. The reports of major bleeding events in the RE-LY clinical trial prompted an FDA investigation in December 2011.
Pradaxa maker, Boehringer Ingelheim, allegedly reported a minimum of 260 fatal bleeding events associated with the drug between March 2008 and October 2011. The drug maker also noted a report issued by the Institute for Safe Medication Practices (ISMP) that indicated that, in the first quarter of 2011, Pradaxa was implicated in 932 reports of serious adverse drug events of all types. This included 120 patient deaths and 543 cases that required hospitalization.
Meanwhile lawsuits continue to mount and thousands of federal lawsuits brought over Pradaxa were consolidated in a single multidistrict litigation (MDL) in a federal court in Illinois. Plaintiffs contested Pradaxa safety and alleged that Boehringer Ingelheim neglected to appropriately warn physicians, other healthcare providers, and consumers about the serious bleeding risks associated with Pradaxa and that the drug maker wrongly marketed Pradaxa as being a safer and more convenient alternative to warfarin. This despite research that revealed that Pradaxa caused some bleeding events more frequently than warfarin. Boehringer Ingelheim agreed to settle all of the then-existing 4,000 Pradaxa lawsuits for a total of $650 million in May 2014.