Since Pradaxa was introduced into the marketplace in October 2010, severe complications have been reported thousands of times. Worse still, there were more than 500 reported cases of death due to Pradaxa use in 2011 alone. Pradaxa’s manufacturer, Boehringer Ingelheim, has claimed that such complications are normal for any anticoagulant, but the frequency and severity of Pradaxa’s reported complications and associated deaths greatly outnumber those of similar drugs.
Doctors, other medical professionals, and patients themselves, continue to report many adverse side effects from the use of Pradaxa, including:
- Major bleeding
- Hemorrhagic stroke
- Gastrointestinal bleeding
- Bloody stools
- Kidney failure
- Heart attack
- Gastrointestinal complications
Recent reports show that these severe and dangerous complications are occurring more frequently than indicated in Boehringer Ingelheim’s reported clinical trials. Because of these adverse impacts, the Food and Drug Administration (FDA) and European Medicines Agency have called for additions to Pradaxa’s warning labels and for a review of the reporting and methods used in Boehringer Ingelheim´s clinical trials that lead to Pradaxa´s initial approval by these agencies.
Other parts of the world, including Europe, Japan, and Australia have issued formal warnings and/or recalls detailing the severity of Pradaxa side effects. Please contact us to set up a free evaluation to see if our drug injury attorneys can represent you or loved one with a Pradaxa injury.