More bad news about Pradaxa. As you may know, the FDA decided to investigate the drug, a bloodthinner, less than a month after European regulators asked doctors to exercise caution in its use. At the time, the European Medicines Agency was aware of 256 cases of serious bleeding reported with the drug.
Now, the Institute for Safe Practices, a non-profit, has reported that the FDA has received information on 505 more cases of hemorrhaging reported in the first quarter of 2011. The cases resulted in death, disability, hospitalization and other serious outcomes, and the median age of the patients was 80.
Earlier this week, a meta analysis of seven clinical trials was published in the Archives of Internal Medicine which found that Pradaxa was "significantly associated with a higher risk" of heart attacks and acute coronary syndrome.
We will keep you updated about this drug, which is manufactured by Boehringer Ingelheim.