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Pradaxa Bleeding Side Effects Lawsuit FAQ

What is Pradaxa?

Pradaxa is an anticoagulant, which means that it is used to stop blood from clotting. It is used to reduce the risk of blood clots in patients who have non-valvular atrial fibrillation (an abnormal heart beat).

Pradaxa, known generically as dabigatran etexilate, is made by Boehringer Ingelheim.

What are the concerns about Pradaxa?

Pradaxa has been linked to an increased risk of uncontrollable bleeding, including life-threatening and fatal events in some patients. Because Pradaxa is an anticoagulant, there is a risk that once a patient starts bleeding the blood will not clot properly, causing the bleeding to continue. This means that even a minor event, such as a fall or a relatively small cut, could result in serious bleeding events.

There is currently no antidote for Pradaxa; although in June 2014, Boehringer Ingelhiem won fast-track status for a potential Pradaxa antidote. That drug, idarucizumab, has been shown in preliminary trials to reverse Pradaxa’s effects.

What does the FDA say about Pradaxa?

Following a safety review announced in 2011 into the risk of uncontrollable bleeding associated with Pradaxa, the FDA stated that Pradaxa provides an important health benefit when used as directed. According to an FDA study on the risk of bleeding events in Pradaxa compared with Warfarin (a similar medication), the rate of bleeding events was similar in both drugs.

What is the difference between Pradaxa and Warfarin?

The main difference between Pradaxa and Warfarin when it comes to risks is that there is a known antidote to Warfarin. Patients who develop uncontrollable bleeding while taking Warfarin can be treated with vitamin K to help the blood clot properly.

An antidote has been developed for Pradaxa but it has just received its fast track for accelerated approval.

Have there been lawsuits concerning Pradaxa?

Yes, lawsuits have been filed against the maker of Pradaxa, alleging patients were not aware that there was no antidote to treat uncontrollable bleeding linked to Pradaxa use.

In June 2014, Boehringer Ingelheim announced a $650 million settlement in approximately 4,000 pending claims against the company.

What should I do if I currently take Pradaxa?

If you are currently taking Pradaxa and you are concerned about the risk of side effects, talk to your doctor about your alternatives. Do not stop medication without seeking medical advice.

Seek medical attention immediately if you suffer an injury - especially an injury to the head - while on Pradaxa. Because of the risk of uncontrollable bleeding, it is important to have injuries, including internal injuries, assessed right away.

Seek medical attention also if you have unusual bleeding, such as nosebleeds, bleeding from gums or coughing up blood.
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Last updated on Jul-2-14

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