dabigatran Tagged Articles
Officials offer theories why Pradaxa associated with so many bleeding events
Theories abound as to why bleeding risks with the blood thinner Pradaxa (dabigatran) appear greater than the long-used Coumadin (warfarin). In a perspective published online in the New England Journal of Medicine, Food and Drug Administration (FDA) officials speculate the
Atrial fibrillation patients should be aware of risks associated with Pradaxa vs. Warfarin
Anticoagulants are often given to patients with a type of heart rhythm abnormality known as atrial fibrillation to prevent strokes. The reasoning is that in people with atrial fibrillation, the upper chambers of the heart pump abnormally causing blood to
Antidote in development for new blood thinners Xarelto, Eliquis
Four drug companies have signed on to fund Protola Pharmaceuticals’ experimental antidote for reversing the effect of Factor Xa inhibitor drugs, blood thinners that block the activity of clotting Factor Xa and prevent blood clots from developing or getting worse.
Anti-clotting drug Eliquis gets FDA approval
Eliquis, a new anti-clotting drug developed by Bristol-Myers Squibb and Pfizer as an alternative to the decades-old warfarin (Coumadin), has finally won approval from the U.S. Food and Drug Administration (FDA).
Boehringer Ingelheim updates Pradaxa label to include heart valve contraindication
Boehringer Ingelheim announced that labels of its blood thinner Pradaxa (dabigatran) will be updated to include a new contraindication related to use in patients with mechanical prosthetic heart valves. The decision to add the new contraindication was made after an
Clinical trial on blood thinner Pradaxa terminated due to safety concerns
A clinical trial studying the stroke and blood clot preventative effects of the blood thinner Pradaxa (dabigatran) in patients with mechanical heart valves was terminated after an interim review of the data by the trial’s Data Safety Monitoring Board.
Bayer expects to reap billions from new blood thinner Xarelto
Bayer is banking on five of its prescription drugs to bring in more than $7 million in annual sales, including its blood thinner Xarelto (rivaroxaban), which is approved for various uses in 120 countries, including the United States. Bayer also
FDA’s latest Pradaxa advisory doesn’t mention the drug’s fatal flaw
In its most recent safety review of Pradaxa (dabigatrin), the U.S. Food and Drug Administration (FDA) says that the risk of serious bleeding associated with the new anticlotting drug appears to be no higher than the bleeding rates associated with
FDA issues update on ongoing review of serious bleeding with blood thinner Pradaxa
The Food and Drug Administration (FDA) announced it has evaluated new information about the risk of serious bleeding associated with use of the blood thinners dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics), and determined that bleeding rates with Pradaxa