Pradaxa is a popular anticoagulant that is usually prescribed to those who have a high risk of stroke or blood clots. However, Pradaxa bleeding reversal has become a concern for those who have experienced severe bleeding events associated with the blood thinning drug.

Pradaxa (dabigatran) was approved by the U.S. Food and Drug Administration in 2012 and was marketed as being a better drug than warfarin, an older drug used to treat blood clots. Pradaxa is manufactured by Boehringer Ingelheim.

Supposedly, patients using Pradaxa need less close monitoring, and using the medication does not require the patient to change his or her diet.

The problem Pradaxa users experienced that warfarin users did not experience is that, for a long time, there was no Pradaxa bleeding reversal agent. Patients on any blood thinning medication run a higher risk of uncontrollable bleeding events because of the nature of an anticoagulant.

However, if a patient taking warfarin had an uncontrollable bleeding event, doctors could administer vitamin K to stop the internal bleeding. When Pradaxa was released in 2010, it did not have a Pradaxa bleeding reversal agent.

It was not until the fall of 2015 that the FDA approved Praxbind, a Pradaxa bleeding reversal medication. Unfortunately, it was too late for many patients.

After Pradaxa was released to the market in 2010, the FDA fielded over 300 reports of internal bleeding and gastrointestinal bleeding in just the first 3 months. After a year, 260 fatalities were associated with Pradaxa use from complications like stroke, hemorrhage, internal bleeding and gastrointestinal bleeding.

Until Praxbind was available as a Pradaxa bleeding reversal agent, the only way uncontrollable bleeding could be stopped in a patient on Pradaxa would be to flush the body of the medication through dialysis, a lengthy and unsafe process.

By 2011, Pradaxa had been linked to 542 patient deaths and by 2014, the drug maker had settled more than 4,000 lawsuits for $650 million. Many of these lawsuits allege that Boehringer Ingelheim knew about the deadly risks of Pradaxa but did nothing to warn the medical community, the public or patients.

That same year, the FDA released the results of a study that showed an increased risk of gastrointestinal bleeding in Medicare patients over the age of 64. Even so, the drug maker did not change the drug label to include any warnings of this increased risk.

Praxbind, the Pradaxa bleeding reversal agent, is now available, but was released too late for many patients who experienced an uncontrollable Pradaxa bleeding event.

If you or someone you love has suffered from severe bleeding and you suspect it was as a result of Pradaxa use, you may benefit from speaking with an attorney.