FDA Approves Pradaxa Antidote After Nearly 1,000 Bleeding Deaths

Last week, the U.S. Food and Drug Administration approved the long-awaited drug Praxbind, which works in most patients to reverse the effects of the powerful blood thinning medication Pradaxa.

The antidote, developed by German drug maker Boehringer Ingelheim, who also makes Pradaxa, was granted fast-track approval by the FDA due to its usefulness in emergency settings for patients afflicted with internal bleeding.

As such, Pradaxa becomes the first of the so-called Novel Oral Anti-Coagulants (NOACs), which also include Eliquis and Xarelto, to offer a bleeding antidote. Experts expect this could vault the drug to the top of the $5 billion anticoagulant market.

Unfortunately, release of Praxbind comes after nearly 9,000 patient hospitalizations and 1,000 deaths from Pradaxa internal bleeding. And, Boehringer will now profit from each new patient with severe bleeding emergencies.

Pradaxa Success and Risks

Pradaxa was introduced in 2010 as a safe alternative to the blood thinner warfarin for the millions of patients at risk of stroke from atrial fibrillation. Since Pradaxa didn’t require dietary changes or frequent blood testing like warfarin, it gained instant popularity among doctors and patients.

What followed was millions of patients switching to the new style anticoagulant due to its ease of use. However, most people didn’t know the full risks. Pradaxa lacked an antidote like warfarin’s vitamin K to stop internal bleeding in emergencies.

As of this writing, the official FDA tally of patient deaths attributed to Pradaxa stands at 973. However, experts say the agency’s database only captures a fraction of the true amount. And, more than 9,000 have faced hospitalization during uncontrollable bleeding.

Pradaxa Lawsuits Raise Awareness to Dangers

In 2012, the federal Judicial Panel on Multidistrict Litigation certified the first consolidation of Pradaxa lawsuits to a court in Southern Illinois. What followed were more than 4,000 cases from across the country as victims saw their struggles weren’t unique.

Numerous health advocates started tracking the amount of adverse event reports filed with the FDA over Pradaxa side effects, and court filings even suggested the drug maker knew of the risks and concealed valuable safety studies from the public.

Rather than face a public trial, Boehringer agreed to a settlement of $650 million in 2014 to resolve the first wave of Pradaxa litigation. But this year, lawyers began a new round of cases to help the thousands of patients that had yet to receive compensation. Those cases are still being filed.

Effectiveness of Pradaxa Antidote

The new bleeding antidote Praxbind is known specifically by its chemical name idarucizumab. It is administered by an intravenous injection and works by binding to Pradaxa to neutralize its effects, hence the brand name.

The approval by the FDA came after Praxbind was shown to be effective in three separate clinical trials covering over 400 patients, both those who were healthy and those suffering from uncontrollable internal bleeding.

In the healthy patients, a dose of Praxbind caused an immediate reduction in the concentration of Pradaxa in the bloodstream that lasted for more than 24 hours.

In those patients suffering an internal bleeding emergency or needing surgery, Praxbind stopped the blood thinning effects of Pradaxa in just 4 hours for 89% of participants.

So far, the recorded side effects for Praxbind are limited, including headaches, constipation, pneumonia and fever.

As part of the FDA’s accelerated approval of Praxbind, Boehringer will be required to provide ongoing test data on the effectiveness of the drug after it is released to market.

For more information on the drugs Pradaxa and Praxbind, or to speak with a lawyer about the ongoing litigation, contact DrugNews today.

Sources:

Cassels, C. FDA Approves Praxbind to Reverse Anticoagulant Pradaxa. MedScape. (October 16, 2015). Retrieved from www.medscape.com

Helfand, C. Boehringer looks for Pradaxa boost from now FDA-approved antidote. FiercePharma. (October 16, 2015). Retrieved from www.fiercepharma.com