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Your search for dabigatran returned 6 results

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Pradaxa Label Updated with New Contraindication

Boehringer Ingelheim announced that the prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
Safety Alerts and Recalls, Uncategorized

Single Lot of Pradaxa 75mg Recalled

Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
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FDA Updates on Bleeding Risk of Pradaxa

The FDA's recommendations regarding Pradaxa remain unchanged following the November 2012 Mini-Sentinel evaluations. Findings showed that bleeding rates associated with Pradaxa use during the period did not appear to be higher than those associated with warfarin.
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FDA: Pradaxa vs. Warfarin Study Results Announced

The FDA announced the results of a new study on Medicare patients comparing Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim Pharmaceuticals) vs. warfarin for risk of ischemic or clot-related stroke, bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death.