FDA reviews Pradaxa bleeding risk
Post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate), a blood thinner from independent German drug major Boehringer Ingelheim, are being evaluated by the US Food and Drug Administration.
Approved late last year to reduce the risk of stroke and blood clots (systemic embolism) in patients with non-valvular atrial fibrillation (The Pharma Letter October 20, 2010), Pradaxa is available as 75mg and 150mg oral capsules. The drug is forecast to achieve annual sales of $1.3 billion by 2018. According to the FDA, from approval in October 2010 through August 2011, a total of around 1.1 million Pradaxa prescriptions were dispensed and about 371,000 patients received Pradaxa prescriptions from US outpatient retail pharmacies.1
Drug has important health benefits when used as directed, says agency
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