For more information or confidential assistance
Call 800-306-3180

Pradaxa Bleeding Complications Lead to FDA Risk Analysis

Since obtaining FDA approval in 2010, dabigatran (Pradaxa) has been under scrutiny for adverse bleeding events. In a December 2011 Pradaxa FDA warning, the agency stated, “Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies.”

However, Pradaxa lawsuits allege that, unlike anticoagulants like Coumadin (Warfarin), there is no antidote to reverse the anticoagulant effects of Pradaxa. Manufacturer Boehringer Ingelheim failed to educate medical professionals on measures that would stabilize and treat a patient experiencing uncontrolled bleeding, say plaintiffs.

The FDA released a December 2013 announcement that they would be taking a closer look at these claims and zeroing-in on Pradaxa bleeding complications, specifically, as part of a large-scale safety assessment.

FDA examines Pradaxa bleeding complications in new study

The first Pradaxa FDA warning in 2011 stated that 1.1 million prescriptions were dispensed for the drug from October 2010 through August 2011. In a large clinical trial involving 18,000 patients, major bleeding events were comparable between Pradaxa and Warfarin patients.

The FDA also emphasized that the benefits seemed to outweigh the risks for most patients, when used as directed. However, they added that they were “working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected,” and that they would publish the findings when available.

On December 30, the FDA proposed a “one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of dabigatran or warfarin.” The agency plans to examine the rates of bleeding and thromboembolic events associated with the use of the drugs using electronic data from the FDA Mini-Sentinel Distributed Database of nearly 100 million patients.

Forbes cites a “knowledgeable source” who says the main purpose of the study will be to “identify groups of patients who are at high risk for major bleeding events with dabigatran.”

Boehringer Ingelheim downplays latest Pradaxa FDA warning

Some eyebrows have raised because the FDA assessment does not include other new oral anticoagulants like Johnson & Johnson’s Xarelto or Pfizer’s Eliquis – which reinforces concerns that Pradaxa may pose an especially high risk of bleeding among others in its class.

However, Boehringer Ingelheim hopes that the study will identify groups of patients who are most likely to benefit from treatment with dabigatran. They also echoed the FDA’s original statement that examining data through Mini-Sentinel “does not necessarily mean there is a safety issue with the product.”

They argue that previous assessments came back showing that Pradaxa was no more dangerous than Warfarin, and that the FDA has not changed their overall recommendation regarding the use of Pradaxa to reduce the risk of stroke and embolism in patients with atrial fibrillation.

Pradaxa lawsuits underscore the need for answers

Most lawsuits regarding Pradaxa bleeding complications are consolidated in MDL #2385 in the Southern District of Illinois under Judge David Herndon. As of December 2013, there were 1,883 cases pending in the federal court system.  In the absence of another official Pradaxa FDA warning, their latest announcement is still likely to raise suspicion and fuel the filing of more lawsuits.

Additionally, new research backs the cause for concern. Contrary to earlier findings, the Institute for Safe Medication Practices published a study in October 2013 indicating that there were 3,200 reports of Pradaxa bleeding complications, including 582 deaths – compared to 861 reports of Warfarin bleeding complications, including 56 deaths. They concluded that the rate of complication for Pradaxa users was five times higher than Warfarin users.

  1. FDA Drug Safety Communication – Safety Review of Post-Market Reports of Serious Bleeding Events With Pradaxa

  2. Mini-Sentinel – Protocol for Assessment of Dabigatran

  3. Forbes – FDA Plans New Safety Assessment of Dabigatran (Pradaxa)

  4. ISMP – Update on Pradaxa