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Three major updates were added to the prescribing information for Pradaxa capsules, an oral anticoagulant. One included a warning that discontinuing treatment puts patients at increased risk of stroke.

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

Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.