Pradaxa is a medication that was designed to prevent strokes in patients who suffer from atrial fibrillation, an irregular heartbeat condition common among the elderly. It works by inhibiting the enzyme that is responsible for clotting blood. However, sometimes it works too well. When a patient who is using a drug like Pradaxa suffers a serious bleeding event, their blood fails to clot and can sometimes lead to the patient bleeding to death.
As a result of these side-effects, many Pradaxa lawsuits were and are still being filed. There has been at least one major Pradaxa settlement. More may be on the way.
Pradaxa was first approved for use in the U.S. in October 2010, but it is not purely a domestic issue. The FDA is not the only entity concerned with internal bleeding deaths. European regulators have recommended that patients who are about to start a Pradaxa regimen should first have their kidneys checked. An individual with weakened kidneys has a higher risk of suffering internal bleeding.
Japanese regulators required manufacturer Boehringer Ingelheim to issue a strong warning to physicians regarding the potentially deadly bleeding caused by the use of Pradaxa.