Uncategorized
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.
Uncategorized
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.
Uncategorized
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
Boehringer Ingelheim announced that it is conducting a nationwide recall of a single manufacturing lot of Pradaxa (dabigatran etexilate mesylate) capsules 75mg.
Uncategorized
The FDA evaluated new information about the risk of serious bleeding associated with use of dabigatran (Pradaxa; Boehringer Ingelheim) and warfarin (Coumadin, Jantoven, and generics).
Uncategorized
The FDA has notified healthcare professionals that it is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim).
Uncategorized
The FDA is alerting healthcare providers and patients of important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate capsules; Boehringer Ingelheim).
