Approved by the FDA in October 2010, Pradaxa (Dabigatran) is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., to reduce the risk of strokes and blood clots in people who have atrial fibrillation, a common heart rhythm abnormality. Pradaxa is in a class of anticoagulant medications known as “blood thinners.”

Pradaxa is a direct thrombin inhibitor. It prevents the formation of blood clots by counteracting the effects of thrombin, which is responsible for clotting. Boehringer Ingelheim Pharmaceuticals markets Pradaxa as the preferred blood thinner. It became the first alternative to warfarin for this indication.

According to Boehringer, it is easier to dose, requires less monitoring, and is more effective at preventing clots compared to warfarin (Coumadin). However, unlike warfarin, Pradaxa’s anticoagulation effect cannot be reversed with vitamin K, significantly increasing the odds that a bleeding event will turn fatal.

To date, there have been significant numbers of fatal bleeds reported to the FDA. The lack of a reversal agent is believed to be the cause of the significant number of bleeding-related adverse events.

Within the first 14 months of its approval, Pradaxa was linked to more than 900 gastrointestinal bleeds and 500 bleeding deaths. Boehringer, in an official statement on November 2, 2011, linked about 50 bleeding deaths to Pradaxa, which Boehringer asserted is consistent with expectations from the Pradaxa clinical trials.

Earlier this year, the FDA required Boehringer to modify the Pradaxa warning label to reflect the lack of a reversal agent, which had not been included in the original warnings. The FDA is currently evaluating the reports of bleeding deaths and investigating whether the rate of severe bleeding reports is higher than what was seen in Pradaxa clinical trials. At this point, there is no black box warning for Pradaxa.

However, in February 2013, the FDA approved new language on Pradaxa’s safety label to include new warnings, precautions and contraindications informing patients not to take the drug if they have ever had or plan to have a valve in their hearts replaced. The updated safety label and medication guide comes after an interim analysis of results from a study showed increased incidents of thromboembolic events (blood clots) and bleeding events in patients with mechanical prosthetic heart valve replacements who used the new anticoagulant.

Beasley Allen is currently investigating claims of GI bleeding, hemorrhagic strokes or any other serious or fatal bleeding involving Pradaxa.



We're here to help!

We live by our creed of "helping those who need it most" and have helped thousands of clients get the justice they desperately needed and deserved. If you feel you have a case or just have questions please contact us for a free consultation. There is no risk and no fees unless we win for you.

Fields marked    may be required for submission.
  1. I'm an attorney

Staggering opioid sales in small-town West Virginia...

A Congressional committee wants to know how two drug wholesalers could send 20.8 million prescription...

Beasley Allen files opioid lawsuit on behalf of the...

Beasley Allen has joined Alabama Attorney General Steve Marshall in filing a complaint on behalf of the...

Opioid overdoses decrease American life expectancy for...

It’s been called an epidemic and a national health emergency, and it has probably affected someone you...

More than 6,000 lawsuits pending in MDL against...

The U.S. Judicial Panel on Multidistrict Litigation reports that there are now 6,121 lawsuits in a...
Risperdal Side Effects

Risperdal plaintiff granted retrial against J&J,...

Like thousands of other plaintiffs, W.C. alleges the defendants didn’t adequately warn about the risk...

Beasley Allen representing Houston County against...

In the second lawsuit filed in two days on behalf of a local government, Beasley Allen is representing...

Highly recommended

I would highly recommend this law firm to handle any of your legal needs.

—Sandy