FDA Calls Pradaxa Reversal Agent “Breakthrough”

pradaxa reversal agent According to a recent press release by Pradaxa manufacturer Boehringer Ingelheim Pharmaceuticals, the Federal Drug Administration (FDA) has granted Breakthrough Therapy Designation to an in-the-works antidote for Pradaxa bleeding problems.

The Pradaxa reversal agent, idarucizumab, is not yet available for clinical use but is being investigated in a worldwide study being conducted at 500 sites in 35 countries.

Pradaxa reversal agent in the works

Pradaxa has been used in the U.S. since 2010 when the FDA approved it to treat atrial fibrillation. It became a popular competitor to the long-used warfarin based on its alleged ease of use – Pradaxa was marketed as needing less physician monitoring than warfarin. But soon after its release, patients began coming forward with Pradaxa bleeding problems.

Patients on blood thinners are generally at risk for internal bleeding but bleeding from warfarin can be halted with a dose of Vitamin K; there is no similar antidote for Pradaxa bleeding that is currently available on the market.

Thousands of individuals across the country filed Pradaxa lawsuits against Boehringer Ingelheim, the manufacturer. The lawsuits were filed in both state and federal courts; in 2012, many of the federal lawsuits were consolidated in multidistrict litigation (MDL) in the United States District Court for the Southern District of Illinois in East St. Louis, Illinois.

The lawsuits alleged that the manufacturer:

Hid the risks of serious injuries, including uncontrolled internal bleeding
Did not fully research the drug’s safety or proper dosing
Neglected to require instructions for care during use of the drug, which is marketed as being low-maintenance

The Pradaxa FDA-approved warning label does indicate that use comes with a risk of serious bleeding but it does not indicate that the bleeding cannot be reversed. The manufacturer had admitted that there was no antidote to stop Pradax-related bleeding but attempts to control it with Vitamin K were complete failures.

$650 million to settle Pradaxa bleeding claims

Earlier this year, Boehringer Ingelheim announced that it had agreed to pay $650 million to settle about 4,000 U.S. lawsuits arising from side effects of its anticoagulant. The Pradaxa settlement was facilitated by the judge presiding over federal multidistrict litigation (MDL) pending in United States District Court for the Southern District of Illinois but was to resolve claims in state courts as well.

Impact of Pradaxa reversal agent

According to a press release by Boehringer Ingelheim, a Phase I study showed that the Pradaxa antidote had an immediate and complete reversal effect on anticoagulation. There is no doubt that a reversal agent to halt Pradaxa bleeding would be a game-changer for the drug.

While Pradaxa and warfarin were reported to have similar rates of extreme bleeding, the lack of an antidote for Pradaxa bleeding meant that all one could do was wait for the body to process the Pradaxa. But some suspect that the effects of Pradaxa slow down the process, allowing the excessive bleeding to go on for hours or more.

The Pradaxa reversal agent is not yet available on the market so those who are currently taking the medication or have taken it in the past are still at risk of injury.