A blood thinner study claims that Pradaxa adverse reports indicated more than twice the number of bleeding-related deaths when compared to warfarin.

The Pradaxa study published by the National Institutes of Health (NIH) set out to retrospectively examine the FDA Adverse Event Reporting System database that collects consumer reported drug-related bleeding events and bleeding fatalities.

Between October 2010 and December 2011, researchers collected data to compare the two anticoagulant medications. Pradaxa was named in 9,029 adverse reports while Warfarin had 2,038 reports.

Out of these numbers, Pradaxa deaths were reported in 348 cases or 15 percent while Warfarin fatalities were named in 46 cases or seven percent.

Researchers concluded that based on the number of U.S. consumers taking Pradaxa, they estimate a bleeding related death could occur in 150 per 100,000 patients.

The blood thinner study further concluded that although the FDA Adverse Event Reporting System is “subject to significant bias,” the numbers suggest that Pradaxa-related deaths are much higher in real-world clinical practice than in controlled clinical trials.

 Pradaxa Complications

Warfarin (Coumadin) dominated the blood thinner market for more than 50 years until Pradaxa was FDA approved. Pradaxa arrived on the U.S. market in 2010 as a new anticoagulant able to treat atrial fibrillation as well as blood clots.

However, the blood thinner has been on the market for five years without a Pradaxa antidote, which means that patients are unable to reverse a bleeding event should one occur.

Unlike Coumadin users who can be given a dose of vitamin K to get a bleeding event under control, Pradaxa patients have to undergo blood transfusions in order to get the medication out of their system.

Thousands of Pradaxa consumers have filed a Pradaxa lawsuit claiming that they were unaware of there was no bleeding reversal agent.

FDA Fast-Tracks Reversal Agent

In October, the FDA announced they were granting accelerated approval for the first Pradaxa antidote  known as Praxbind. The agency signed off on the medication after three trials for safety and effectiveness.

According to the FDA, one of the trials using Praxbind found that “the anticoagulant effect of Pradaxa was fully reversed in 89 percent of patients within four hours of receiving Praxbind.” The intravenous injection works as a Pradaxa antidote by “binding to the drug compound to neutralize its effect.”

Pradaxa Bleeding Lawsuits

Although the Pradaxa antidote is good news for current Pradaxa consumers, thousands of former patients have already filed lawsuits against Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals over allegations of placing sales over patient safety and failing to warn about the severe side effects of the medication

Plaintiffs allege Pradaxa side effects include: internal bleeding, kidney bleeding, gastrointestinal bleeding, heart attack, stroke, brain hemorrhage and even death.

In 2014, Pradaxa manufacturer agreed to settle 4,000 Pradaxa lawsuits for $650 million, which awarded each plaintiff $162,500.

If you took Pradaxa and experienced severe side effects including Pradaxa internal bleeding, contact a Pradaxa lawyer to find out if you have legal claim.