The history of Pradaxa and the FDA is short but interesting. he U.S. Food and Drug Administration (FDA) approved Pradaxa in October, 2010. Just over a year after approving the drug, the agency announced that it is conducting a safety review of the drug, due to reports of serious bleeding events. If you have been harmed by Pradaxa, please talk to a Pradaxa attorney today.
Pradaxa was approved based on a large clinical trial which showed that the drug carried a similar rate of bleeding events as warfarin. Now the FDA is questioning that, and evaluating the post-market reports of bleeding events to determine if it is causing bleeding at a higher rate than was expected based on the trial results.
Patients are warned not to stop taking Pradaxa without doctor supervision because of the risk of stroke, but to be on the lookout for signs of a bleeding event including:
- Bleeding gums
- Nose bleeds
- Unexplained bruises
- Bruises that grow
- Coughing up blood
- Vomiting blood or vomit that looks like coffee grounds
- Pink or brown urine
- Red, black, or tarry-looking stools
- Dizziness
- Weakness
- Unusually heavy menstrual bleeding
- Any unusual or excessive bleeding
If you or someone you love has been injured by Pradaxa, please call our Pradaxa attorney Jack Hickey at 1-800-215-7117 or submit an online questionnaire.