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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.
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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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Alere has issued a voluntary correction to users of the Alere INRatio and INRatio 2 PT/INR Monitor system of certain medical conditions that should not be tested with the system.
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Upsher-Smith Laboratories announced a nationwide voluntary recall of Jantoven (warfarin sodium) 3mg tablets with an expiration date of September 2012, Lot #284081NDC #0832-1214-00.
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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.
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Upsher-Smith Laboratories is voluntarily expanding its previously announced recall of Jantoven (warfarin sodium) 3mg tablets to include additional products that were packaged on the same packaging line between May 17, 2010 and November 17, 2010.
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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).
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Bristol-Myers Squibb announced a voluntary recall of several lots of Coumadin (warfarin sodium) 1mg tablet blister packs.
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Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled.
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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.
