A recent blood thinner study compared Pradaxa to warfarin (Coumadin) and discovered that patients taking Pradaxa face an 85% increased risk of gastrointestinal bleeding.
The study, published in JAMA Internal Medicine, analyzed the records of more than 9,400 patients taking either medication. Researchers concluded that Pradaxa users had an overall 50% higher risk of internal bleeding in addition to the 85% increased risk of gastrointestinal bleeding.
Similarly, another study published by the National Institutes of Health (NIH) found that Pradaxa patients reported double the amount of bleeding related deaths compared to Warfarin.
Researchers examined the FDA Adverse Event Reporting System and analyzed the data collected between October 2010 and December 2011. In that time, Pradaxa was named in 9,029 adverse reports while Warfarin had 2,038 reports.
Pradaxa deaths were reported in 348 cases or 15% while Warfarin fatalities were named in 46 cases or 7%.
When Pradaxa was released on the U.S. market there was no reversal agent for patients who suffer from an internal bleeding event. Unlike Warfarin users, who can be given a dose of vitamin K to get a bleeding event under control, Pradaxa patients had to undergo blood transfusions in order to get the medication out of their system.
After five years on the market, the FDA announced in October that they were fast-tracking approval for the first Pradaxa antidote known as Praxbind. The federal agency signed off on the medication after three trials for safety and effectiveness. The FDA reported that the reversal agent was able to stop bleeding events in 89 percent of patients within four hours.
Pradaxa bleeding symptoms include:
•Unusual or unexplained bruising
•Frequent nose bleeds
•Bleeding from the gums
•Red or black stools
•Coughing up blood
Other Pradaxa side effects include: Kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage and even death.Pradaxa has already agreed to settle 4,000 Pradaxa lawsuits for $650 million, which awarded each plaintiff $162,500.