Pradaxa Bleeding Side Effects Lawsuit

Pradaxa side effects reportedly include a risk of Pradaxa bleeding, according to reports from the European Medicines Agency. Pradaxa, known generically as dabigatran, has been linked to between 50 and 256 deaths that reportedly involved Pradaxa side effects. Some victims have filed a Pradaxa lawsuit alleging excessive bleeding.


Pradaxa is an anticoagulant (used to prevent blood clots) medication designed to replace warfarin. It is used to prevent strokes in patients who suffer from atrial fibrillation. Patients with atrial fibrillation may be at a higher risk of blood clots, which can cause a stroke if they travel to the brain. In some countries, Pradaxa is approved to prevent venous thromboembolism, although it is not approved in the US for this use.

Pradaxa has been linked to an increased risk of bleeding, a common side effect in anti-blood clotting medications.

In December 2011, the US Food and Drug Administration (FDA) announced it was conducting a safety review of Pradaxa. The announcement was made after FDA received postmarketing reports linking the use of Pradaxa to serious bleeding events. When the FDA made its announcement, it said that it currently believes the medication provides an important health benefit and patients should not discontinue medication without speaking to their healthcare provider.

Although the Pradaxa warning label contains information about the risk of bleeding, the FDA is working to determine whether bleeding events are occurring with Pradaxa patients more frequently than expected. According to Pradaxa's maker, there were reportedly 260 reports of fatal bleeding incidents worldwide associated with Pradaxa use.

A study published in January 2012 in the Archives of Internal Medicine suggested a link between the use of Pradaxa and a slightly higher risk of heart attack or acute coronary syndrome when compared with similar medicines. Researchers compared the use of Pradaxa to warfarin, enoxaparin or a placebo and found that the relative increase in risk ranged from 27 to 33 percent in patients who used Pradaxa.

Researchers recommended that further study be done on the increased risk of heart attacks in patients who take Pradaxa and that clinicians weigh the risks of Pradaxa along with the benefits.

Pradaxa is made by Boehringer Ingelheim. It was approved for use in October 2010 and is known as a direct thrombin inhibitor. Pradaxa is available in 75 mg and 150 mg capsules.

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Last updated on May-7-15