Latest Dabigatran Stories

RIDGEFIELD, Conn., Dec. 19, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. 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 decision to add the contraindication was made following an interim analysis of results from the Phase II RE-ALIGN(TM) study in patients with mechanical...

The Drug Risk Resource Center is the Web’s largest source for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com New York, NY (PRWEB) December 12, 2012 The DrugRisk Resource Center is alerting patients taking the blood thinner Pradaxa that reports of side effects to the FDA have topped 20,000. Also, the maker of the drug faces growing litigation over alleged bleeding injuries and deaths. According to the Adverse Events Report on...

ATLANTA, Dec. 8, 2012 /PRNewswire-USNewswire/ -- Studies presented today at the 54th( )Annual Meeting of the American Society of Hematology (ASH) examine current treatment standards for patients with clotting disorders in an effort to improve outcomes. The studies evaluate long-held treatment standards and whether modifications in intensity and duration of therapy may offer equally effective outcomes while reducing toxicities and relapse rates. Although significant advances have...

RIDGEFIELD, Conn., Dec. 8, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from two new post-hoc sub-analyses comparing the clinical management and outcomes of patients who experienced major bleeding while treated with dabigatran or warfarin. These findings from the RE-LY® trial and four other Phase III trials report outcomes after a major bleed on dabigatran, despite the lack of a specific reversal agent, may be better than after a...

The Drug Risk Resource Center is the Web’s largest source for information on prescription drug research, side effects and legal news. Visit http://www.DrugRisk.com New York, NY (PRWEB) December 07, 2012 The DrugRisk Resource Center is alerting patients taking the blood thinner Pradaxa that an alternative drug Eliquis, which awaits approval in the United States, was recently approved in Europe. The news comes as the latest report from the Judicial Panel on MultiDistrict Litigation shows...

Although current guidelines recommend 3 months of anticoagulation treatment after bioprosthetic aortic valve replacement surgery, a study that included more than 4,000 patients found that patients who had warfarin therapy continued between 3 and 6 months after surgery had a lower rate of cardiovascular death, according to a study in the November 28 issue of JAMA. "Biological prostheses are preferred to mechanical valves for aortic valve replacement (AVR) surgery in elderly patients older...

RIDGEFIELD, Conn., Nov. 7, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim results from the RELY-ABLE(®) trial, a long-term extension of the RE-LY(®) study. During more than two years of randomized follow-up, key safety outcomes such as major bleeding, total bleeding and life threatening bleeding were similar to the results of the dabigatran 110mg* and 150mg arms of the pivotal RE-LY trial that evaluated Pradaxa(®) (dabigatran etexilate...

RIDGEFIELD, Conn., Nov. 7, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that it is conducting a nationwide voluntary recall of a single manufacturing lot of Pradaxa(®) (dabigatran etexilate mesylate), 75mg 60 US, NDC 0597- 0149-54, lot 201900, Exp January 2015. PRADAXA is indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). The recall is limited to this one lot number. (Photo:...

RIDGEFIELD, Conn., Nov. 2, 2012 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa(®) (dabigatran etexilate mesylate) capsules do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the pivotal RE-LY(®) trial. The Mini-Sentinel assessment evaluated new information about the risk of...

RIDGEFIELD, Conn., Oct. 30, 2012 /PRNewswire/ -- Boehringer Ingelheim will present data from 16 abstracts at the American Heart Association's (AHA) Scientific Sessions in Los Angeles from November 3 to 7, 2012, including data on Pradaxa(®) (dabigatran etexilate mesylate) capsules and data evaluating patients with non-valvular atrial fibrillation (NVAF). These data reinforce BI's commitment to adding to the scientific body of evidence for PRADAXA and stroke prevention in NVAF....