Pradaxa Receives Additional FDA Approval Despite Growing Bleeding Lawsuits

Thursday, December 10, 2015
Pradaxa Anticoagulant

Three novel oral anticoagulant medications – Pradaxa, Xarelto and Eliquis, have battled it out in recent years to grab their share of an estimated $6 billion blood thinning drug market once dominated by the generic drug warfarin.

And while each has promised it is safer and easier to use than warfarin, Pradaxa and Xarelto have been plagued by thousands of reports of patients suffering extended hospitalization or death from internal bleeding. So far, more than 5,000 lawsuits have surfaced alone for Pradaxa bleeding.


New Pradaxa FDA Approval for Hip Replacement Patients

Now, the FDA has granted Pradaxa access to hundreds of thousands of additional patients with the approval last month for the medication to be prescribed to those recently undergoing hip replacement surgery.

Each year, around 300,000 patients have artificial hips implanted, and around half of those are at risk of a serious blood clot like deep vein thrombosis unless they use a blood-thinning drug.

Originally approved to prevent blood clots and strokes in patients with non-valvular atrial fibrillation, Pradaxa received additional approved uses by the FDA in recent years to treat and prevent DVT and pulmonary embolism blood clots in patients that had already received other treatments.


Studies Show Pradaxa Effective for Blood Clots But With Bleeding Risks

This latest approval by the FDA for use in hip replacement patients marks the fourth designated use for Pradaxa.

It came after studies of more than 5,000 patients following hip replacement surgery in the RE-NOVATE clinical trials demonstrated Pradaxa was more effective at preventing thrombosis (blood clots) than the injectable drug Lovenox.

However, those patients taking Pradaxa during the trials were 50% more likely to suffer major internal bleeding than those receiving the Lovenox injections. Still, the overall death rate reduction due to the blood clot prevention prompted the FDA approval. 


Pradaxa Market Share Declines Since Launch

Pradaxa was the first warfarin-replacement to hit the market in 2010, and quickly grew into a blockbuster drug since patients were told they didn’t need regular drug tests or dietary changes like with warfarin.

However, thousands of patients suffered serious or fatal internal bleeding, and doctors soon learned they had no antidote to stop emergency bleeding like with warfarin.

In subsequent court documents, it was shown that executives from Pradaxa maker Boehringer Ingelheim concealed internal studies suggesting the drug would be safer for patients if they had the benefit of regular blood tests to adjust dosage.

The launch of Xarelto in 2011 and Eliquis in 2012, both with slightly safer trial records, pushed market share away from Pradaxa, as did reports of thousands of patient injuries or death.


Pradaxa Maker Has Paid $650 Million in Compensation So Far

Also hurting Pradaxa’s market share was news that over 4,000 patients had filed lawsuits over serious internal bleeding beginning in 2012. In 2014, rather than face pending trials, Boehringer paid $650 million to settle several thousand Pradaxa side effects lawsuits.

Today, lawyers are still filing claims for patients that were hospitalized with gastrointestinal bleeding or brain hemorrhage after taking Pradaxa. It is estimated an additional 1,000 or more patients have initiated new lawsuits since the last settlement, with more joining every day.


Antidote Launch Could Increase Pradaxa Safety

This October, the FDA approved the first antidote designed to stop internal bleeding in those patients with emergencies. Ironically, the drug, called Praxbind, is also sold by Boehringer Ingelheim. This means the company will profit from serious side effects of its own product, Pradaxa.

DrugNews will continue to track the safety profile of novel oral anticoagulants like Pradaxa, Xarelto and Eliquis.

For more information on the current studies and litigation, or to speak with a lawyer directly about a claim, contact us today.



Brown, T. FDA OKs Pradaxa for Thromboprophylaxis After Hip Surgery. MedScape. (November 24, 2015). Retrieved from

Boehringer Ingelheim Press Release. FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Prophylaxis of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) after Hip Replacement Surgery (November 23, 2015). Retrieved from

FDA approval

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