FDA Allays Pradaxa Concerns

The US Food and Drug Administration declared that the risk of bleeding in patients who are new to Boehringer Ingelheim's blood-clot preventer Pradaxa is not higher than the currently used blood thinner warfarin.

The FDA had earlier approved Ingelheim's Pradaxa for preventing strokes in patients who suffer from atrial fibrillation but safety concerns over the pill emerged following reports that it posed a risk for bleeding in patients who were newly introduced to the drug.

The FDA hopes that this announcement will allay any safety concerns over the pill.

The FDA compared the insurance claims and electronic health data of both warfarin and Pradaxa users from October 2010 to December 2011 and found that instances of intracranial and gastrointestinal hemorrhage in patients taking warfarin was 1.8 to 2.6 times higher compared to Pradaxa. "The results indicate that the observed bleeding rates associated with new use of Pradaxa do not appear to be higher than the bleeding rates associated with new use of warfarin", he FDA said.


Source: Medindia