Topics and Cases - Pradaxa
Pradaxa is a blood thinner primarily prescribed for those with atrial fibrillation. With atrial fibrillation, patients have a higher risk of forming blood clots near the heart which can travel through the body and cause strokes. Pradaxa is used to lower the chance of blood clots forming.
Facts about Pradaxa:
- Pradaxa (dabigatran etexilate) is a blood thinner that was approved by the U.S. Food & Drug Administration (FDA) in October 2010 to prevent blood clots in patients with atrial fibrillation.
- Side effects of Pradaxa include lethargy, unusual bruising/bleeding/hemorrhaing, pink of brown urine, red or black tarry stools, coughing up blood, vomiting that resmebles blood or coffee, bleeding from the gums, frequent nosebleeds, join pain/swelling, headaches, dizziness, weakness and swelling of the arms/hands/feet/ankles/legs, or death
- Pradaxa was marketed as safer than traditional blood thinners, like warfarin. However, warfarin bleeding can be stopped via the administration of vitamin K. There is no antidote for Pradaxa bleeding at this time, making Pradaxa bleeding events potentially far more deadly.
- In 2011, Japan asked the maker of Pradaxa to notify doctors about potentially deadly bleeding or hemorrhaging in some Pradaxa patients. According to a letter sent to Boehringer Ingelheim by the country's health ministry, between March 14 and August 11, 81 elderly patients taking Pradaxa suffered heavy bleeding or hemorrhaging, leading to five deaths. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa.
- In September 2011, Pradaxa became the subject of an investigation in New Zealand after as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding / hemorrhaging.
- Another 36 patients reportedly suffered bouts of serious internal bleeding or hemorrhaging. New Zealand media outlets reported that some families claimed the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in after their conditions had deteriorated to the point of hospital admission.