The FDA announced today that it is now investigating post-marketing reports of serious bleeding events in patients taking dabigatran (Pradaxa®). Dabigatran is a direct and reversible thrombin inhibitor, used as an alternative to warfarin in patients requiring anticoagulation. Dabigatran is FDA-approved for prevention of thromboembolism and/or stroke at a dose of 150 mg twice daily.
Dabigatran is an attractive therapy for a number of reasons. In the large clinical trial (the RE-LY trial) that led to dabigatran’s approval, dabigatran was more effective than warfarin at preventing both ischemic and hemorrhagic stroke (35% risk reduction). Dabigatran dosing is simple and INR monitoring is not required, as it is with warfarin. Dabigatran has far fewer drug-drug and drug-food interactions than warfarin.
In the RE-LY trial, rates of bleeding with dabigatran were similar to warfarin, so it is expected that some patients taking dabigatran would experience bleeding. What the FDA is investigating is whether the number of post-marketing reports of bleeding it is receiving makes sense based on the rates of bleeding found in the RE-LY trial.
The FDA said it will inform the public and clinicians about any new information about bleeding risks when it becomes available. In the meantime, the agency said it believes dabigatran provides an important health benefit when used as directed and that patients taking dabigatran should not stop taking the drug without talking to their doctor.
|That kind of thinking shows you're an exeprt
Posted 4/26/2013 11:31:29 PM
|That's an inevntvie answer to an interesting question
Posted 4/26/2013 11:31:07 PM
|In one of the above comments, I think 80% is quite high on the need of otapies. The state in which I live there is a nice little thing called the BOP (Board of Pharmacy). Any practicing physician can obtain fairly updated records on scheduled drugs, on any patient with a name and DOB. All they need to do is sign up with their information and DEA# and can get this information online instantly. I think all states should be doing this. It is truly a great instrument for discerning dr. shoppers and drug seekers from legit. patients.
Posted 8/5/2012 01:02:33 PM
|On Dec. 7, 2011, the U.S. Food and Drug Administration (FDA) announced that it had began a formal investigation into the 260 reports of fatal Pradaxa® injuries that occurred from March 2008 to October 2011 (a period of approx. 3-1/2 years).
Symptoms of bleeding, one of the many adverse Pradaxa® side effects preceded many of the deaths linked to this anticoagulant drug. The FDA said it will be conducting the investigation to determine if the incidence of bleeding and deaths among patients prescribed Pradaxa® is higher than what would be expected based on observations in the clinical trial that was held before the FDA approved Pradaxa® (dabigatran)
-- pradaxa lawsuit
Posted 6/2/2012 06:22:24 PM
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