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Boehringer Ingelheim announced that the FDA has approved Pradaxa (dabigatran etexilate capsules), an oral direct thrombin inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).

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The FDA has issued a final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks (eg, internal bleeding, liver damage, concomitant warfarin therapy) associated with the use of these drugs and to prominently display the active ingredients on the drug labels of both the packages and bottles.

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Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep injection (tinzaparin sodium) may increase the risk for death, compared to unfractionated heparin (UFH) when used to treat elderly patients with renal insufficiency.

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The FDA has received information about the Innohep in Renal Insufficiency Study (IRIS) that was stopped early because of an interim finding of increased all-cause mortality in patients who received Innohep (tinzaparin sodium injection, from Celgene).