Boehringer Ingelheim Claims Pradaxa Bleeding Events Not So Bad

According to a study sponsored by the drug maker Boehringer Ingelheim, patients fare well after major bleeding events caused by their blood thinner Pradaxa, despite the lack of an antidote to reverse bleeding problems that may arise.  

The study was published online in the medical journal Circulation, comparing outcomes for patients who suffered major bleeding events while taking Pradaxa to patients who suffered bleeding events while taking warfarin; an older blood thinner commonly known by the brand name Coumadin.

Unlike Pradaxa, bleeding events among users of warfarin can typically be stopped through use of vitamin K and plasma, known as a reversal agent. No such antidote exists for Pradaxa, often leaving doctors unable to stop severe bleeds that may occur while using the medication.

The pooled analysis looked at data on 1,034 patients who suffered 1,121 major bleeds while on Pradaxa and compared them to 27,419 patients given warfarin for between six and 36 months. The research found that patients taking Pradaxa tended to be older, and more frequently take aspirin or other non-steroid anti-inflammatory agents.

According to the findings of the study, patients who suffered major bleeding events while on Pradaxa needed more red blood cell transfusions than those on warfarin, but required less plasma. The researchers also found that patients who suffered Pradaxa bleeds had shorter hospital stays and tended to be more likely to survive than warfarin patients, according to the findings.

Overall, the drug company-sponsored investigators said that Pradaxa bleeding events appeared to be “not worse” than warfarin bleeding events, despite the lack of a reversal agent.

Many doctors and health experts have raised serious concerns about the lack of a reversal agent for Pradaxa.

Since Pradaxa (dabigatran) was introduced in October 2010, it quickly became one of the drugs most commonly associated with adverse event reports submitted to the FDA, often involving reports of hemorrhage, death or other problems caused by uncontrollable bleeding.

Pradaxa was the first member of a new class of anticoagulants, which have been promoted as a superior alternative to warfarin for stroke prevention, because it requires less monitoring.

Over the past few years, a growing number of A growing number of Pradaxa lawsuits have been filed against Boehringer Ingelheim that allege that the drug maker failed to adequately warn about the bleeding risk or the lack of a reversal agent for Pradaxa. Plaintiffs allege that they suffered severe and sometimes fatal injuries from hemorrhaging, which doctors were unable to control or stop.