Since the blood thinning drug Pradaxa was introduced in 2010, drug maker Boehringer Ingelheim has faced a growing number of lawsuits based on claims that patients were not warned of serious bleeding risks associated with the drug, nor of the lack of an antidote for Pradaxa internal bleeding.

Now, a reversal agent for potentially fatal Pradaxa internal bleeding is available in hospitals across the United States.

As of March 8, Praxbind has been made available in some 2,200 hospitals across the United States and has been approved as a reversal agent to help stop Pradaxa internal bleeding events.

“Boehringer Ingelheim is proud to have been able to make PRAXBIND, the first specific reversal agent for a NOAC, available, and that we have been able to distribute it broadly nationwide,” Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc, said in the press release issued by the drug maker. “In the rare event that a patient may need PRAXBIND, it is critical that it is readily available.”

Pradaxa Internal Bleeding Problems

Pradaxa (dabigatran) was the first of a new class of blood thinners called novel oral anticoagulants to be introduced in the United States in 2010, and was followed by others including Xarelto and Eliquis.

These drugs were aggressively marketed as superior and more convenient alternatives to warfarin (Coumadin), the leading blood thinner for decades.

Initially, Pradaxa and related drugs appealed to patients who did not want to subject themselves to routine blood monitoring necessary to ensure proper blood clotting in patients taking warfarin.

Additionally, dietary restrictions required for warfarin users also seemed to make Pradaxa a more convenient alternative.

However, many patients now claim that they were not made aware of Pradaxa internal bleeding risks. Additionally, though warfarin internal bleeding events may be stopped with a dose of Vitamin K, there has been no such reversal agent for bleeding in patients taking Pradaxa or other new blood thinners.

This means that patients taking Pradaxa or other similar anticoagulants may not be able to form blood clots to stop internal bleeding, potentially leading to death.

FDA Fast Tracks Praxbind Approval

Last October, the FDA gave accelerated approval to Praxbind (idarucizumab) for emergency situations when the drug is needed to reverse the effects of Pradaxa internal bleeding episodes.

Praxbind’s safety and efficacy was studied in three trials with 238 healthy volunteers who were given Pradaxa and 123 patients on Pradaxa who actually needed the drug.

When Praxbind was administered to the healthy volunteers, researchers found an immediate drop in the amount of Pradaxa in their blood. This reduction lasted for at least 24 hours. The most common side effect was headache.

The 123 Pradaxa patients who got Praxbind needed it as they were having either uncontrolled bleeds or emergency surgery. This trial is ongoing and has thus far shown appreciable success. The time to full Pradaxa reversal in 89% of patients was within four hours.

Too Late for Some

Still, the approval and release of Praxbind has come too late for many patients and grieving families who died from Pradaxa internal bleeding events.  Many of these surviving family members or patients have filed lawsuits against Boehringer Ingelheim.

If you or someone you love has suffered serious injury or even death due to Pradaxa internal bleeding, you could be entitled to compensation for your damages. To learn more, please contact a personal injury lawyer for a free consultation.