Over 1.1 million packages of test strips distributed from January 12, 2018 to October 29, 2018 are being recalled.
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The Food and Drug Administration (FDA) is recommending that patients avoid the concomitant use of sodium polystyrene sulfonate with other oral medications.
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.
Bristol-Myers Squibb announced a voluntary recall of 6 lots of Coumadin for Injection, 5mg single-use vials, in the U.S.
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.
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.
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.
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).
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).
Bristol-Myers Squibb has initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) 5mg tablets because they may contain tablets higher in potency than expected.