Study: Pradaxa and Warfarin Post Surgery Bleeding Rates Similar
Findings from a new study indicate similar rates for bleeding and thromboembolic complications between Pradaxa and warfarin patients when these patients need to undergo surgery.
The American Heart Association journal, Circulation, published a report last week that highlighted more data from the controversial RE-LY clinical trials used to obtain FDA approval in 2010.
Canadian scientists and doctors concluded that warfarin and Pradaxa had similar rates of peri-procedural bleeding. Pradaxa patients were able to stop using the drug closer to surgery than warfarin patients were, to allow the anticoagulant properties to wear off. Patients who took warfarin within 48 hours of surgery were up to three times likely to encounter bleeding problems.
Researchers observed atrial fibrillation patients who needed surgery for 7 days before the procedure, until 30 days after surgery. They found similar rates of cardiovascular death, stroke, pulmonary embolism, and heart attack in Pradaxa and warfarin patients.
Warfarin bleeding problems can be reversed with a dose of Vitamin K, but there is currently no such reversal agent for Pradaxa internal bleeding.
Pradaxa (dabigitran) is made by Boehringer Ingelheim and was approved by the FDA in October 2010 to prevent stroke and blood clots in patients with atrial fibrillation. Though it requires less monitoring than warfarin, it has been linked to thousands of reports of injury and death from internal bleeding.
In an Institute for Safe Medication Practices report released last month, it was reported that the FDA received more adverse event reports concerning Pradaxa than any other drug it monitors.
The RE-LY study, the basis for this report, has been criticized by experts who believe Pradaxa should not have been approved based on trial results.
Researchers from the University of British Columbia state that this trial was fundamentally flawed and that bias and errors affected results.
The FDA continues to investigate Pradaxa adverse event reports, and European regulators recently indicated that the benefits of this drug outweigh the risks. Still, the European Medicines Agency also required stronger warnings to be placed on Pradaxa labels.
Contact a Pharmaceutical Product Liability Lawyer
If you or someone you love has suffered injury or death as a result of Pradaxa internal bleeding, you may be able to collect compensation for your damages in a medical product liability lawsuit. Contact a personal injury lawyer to learn more in a free legal consultation.