FDA goedkeuring dabigatran bij AF patiënten
FDA approves dabigatran for stroke prevention, embolism, in AF patients
October 19, 2010
Late Tuesday, the US FDA announced it has approved dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The drug will be available in two doses: 75 mg and 150 mg.
An advisory panel in September voted 9 to 0 to recommend that the oral antithrombin be approved.The cardiology community has expressed few major reservations about the randomized trial on which the drug's approval application is primarily based, the 18 000-patient Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY). And for a generation, it has longed for an oral antithrombin that's at least as safe and effective as warfarin but is more consistent in its effects and doesn't require cumbersome anticoagulation monitoring.
As with other approved anticlotting drugs, bleeds, both life-threatening and fatal, were among the most common adverse reactions reported by patients treated with dabigatran in studies, an FDA press release notes. Other side effects, including gastrointestinal symptoms, dyspepsia, stomach pain, nausea, heartburn, and bloating also were reported.
Dabigatran was approved with a Medication Guide that details the risk of serious bleeding for patients.