Pradaxa linked to 260 cases of fatal bleeding
The manufacturer of the anticoagulant drug Pradaxa has reported that at least 260 deaths have been linked to excess bleeding caused by the drug. This new report on the number of Pradaxa deaths was more than five times the previous number of fatalities that had been linked to the drug.
Pradaxa was approved by the Food and Drug Administration in October 2011 as an alternative to the anticoagulant drug warfarin (Coumadin), which carries a risk of interaction with some foods and other drugs. Although Pradaxa does not carry these risks, unlike warfarin, the drug does not have a reversal agent or antidote to stop serious bleeding in patients who experience side effects from the drug.
Health officials in Europe and Japan have issued warnings to doctors about the risk of Pradaxa side effects. Despite these warnings, neither foreign health officials or officials with the FDA have announced plans to issue a Pradaxa recall due to the risk of excess bleeding caused by the drug.