FDA finds favorable risk:benefit balance for Boehringer’s Pradaxa

As part of its ongoing review, the US Food and Drug Administration last week released latest findings on German family-owned drug major Boehringer Ingelheim’s anticoagulant Pradaxa (dabigatran) showing an overall favorable risk:benefit for the drug.

The new study in Medicare patients compared Pradaxa to an older blood thinner, warfarin (Coumadin, Jantoven and generics), for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal bleeding, myocardial infarction, and death. Pradaxa and warfarin are used to reduce the risk of stroke and blood clots in patients with a common type of abnormal heart rhythm called non-valvular atrial fibrillation.

The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain and death, compared to warfarin. The study also found an increased risk of major gastrointestinal bleeding with the use of Pradaxa as compared to warfarin. The myocardial infarction risk was similar for the two drugs.