FDA study shows Pradaxa reduces stroke risk but raises chances of GI bleeding

A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate) has found that the drug was associated with significantly reduced risks of ischemic stroke, intracranial hemorrhage and death, and a significantly increased risk of major gastrointestinal hemorrhage, compared with warfarin in patients with non-valvular atrial fibrillation.

Pradaxa, marketed by German family-owned drug major Boehringer Ingelheim, has been the subject of litigation relating to severe and fatal bleeding that plaintiffs allege is caused by the drug.

Sabine Luik, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said: "This is the largest and most rigorous post-marketing study of Pradaxa in routine clinical practice and supports the positive risk/benefit profile of Pradaxa. Patient safety is of utmost importance and we are pleased to see these findings further support the value of Pradaxa as a treatment option for NVAF patients."