The FDA says it conducted an assessment of Johnson & Johnson (JNJ -0.2%) and Boehringer Ingelheim's Pradaxa using insurance claims and administrative data from its safety surveillance program, and found no evidence that the drug increased risk of bleeding when compared with warfarin. The agency launched an investigation of Pradaxa - which is approved to reduce the risk of stroke and embolism in patients with atrial fibrillation - last year after receiving reports of serious bleeding events in patients using the drug.
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