Without the use of an antidote, Pradaxa reversal may take at least 24 hours–which could be critical time in the event of a life-threatening bleed.

Pradaxa is a blood thinning drug that was approved by the U.S. Food and Drug Administration (FDA) in 2010. Many modern blood thinners were designed to compete directly with warfarin, an anticoagulant that has been trusted by the medical industry for 60 years.

Warfarin is relatively safe and, in the case of a life bleeding event, can be easily counteracted by flooding the body with vitamin K. Unfortunately, life threatening bleeding events may be more common than expected with Pradaxa.

Pradaxa and various other new anticoagulant drugs have been linked to internal bleeding, kidney bleeding, gastrointestinal bleeding, and brain hemorrhage, all opening up the possibility for heart attack, stroke, and death.

Pradaxa Safety Problems

In the first three months that Pradaxa was on the market, the FDA reportedly received 307 adverse event reports involving Pradaxa patients suffering from internal bleeding, gastrointestinal bleeding, and other serious health complications.

Within the drug’s first year on the market, the FDA reported over 260 deaths in Pradaxa patients from internal or gastrointestinal bleeding, hemorrhage and stroke.

The safety profile of Pradaxa made it hard for the drug to compete with warfarin until the FDA finally approved an antidote for the drug.

In October 2015, the FDA approved Praxbind, an injectable antidote for Pradaxa. It became the first modern blood thinner to gain an FDA approved antidote. The drug only works with Pradaxa, however, and not with other new anticoagulants. According to Pharmacy Times, this drug is useful to reverse the anticoagulation effects for surgery or emergency bleeding events.

According to the Michigan Anticoagulation Quality Improvement Initiative, Pradaxa takes a few hours to take effect but usually wears off within 24 hours of dosage when an antidote is not used. Around 80 percent of the drug is excreted out of the body through the kidneys and urine, while the rest is excreted through stool.

Although 24 hours may not seem like a long time, these hours could mean life or death when a patient is affected by a life threatening internal bleed.

Praxbind

Before the approval of Praxbind, Pradaxa reversal options were limited. Doctors were forced to rely on supportive therapy, dialysis, off-label usage of 4-factor prothrombin complex concentrate or recombinant factor VIIa, and simply waiting for Pradaxa to wear off. In the case of a life threatening bleed, these options were not ideal and may not have been safe.

Although there is now a safe option for Pradaxa reversal in the case of a life-threatening bleed, countless patients were left with no antidote for around five years between Pradaxa’s approval and Praxbind’s approval. Even now, the availability of Praxbind is not widespread.

Patients and families who were affected by life threatening bleeding before Praxbind became available argue that Boehringer Ingelheim should have given them a better warning about the risk of uncontrollable bleeding. Even today, patients who suffer Pradaxa bleeding may qualify to take legal action against the drug manufacturer for failing to warn consumers about the drug’s serious risks.