Latest Amides Stories
The Firm continues to offer free Pradaxa lawsuit evaluations to victims of serious internal bleeding, allegedly caused by Pradaxa. New York, NY (PRWEB) December 22, 2012 A new Pradaxa side effect warning has been announced by Boehringer Ingelheim, the maker of the blood thinner, Bernstein Liebhard LLP reports. According to an alert issued by U.S. Food & Drug Administration (FDA) on December 19th, the company will be modifying the Pradaxa label to warn that it should not be...
The Drug Resource Center is the Web’s largest source for information on prescription drug warnings, side effects and legal news. Visit http://www.DrugRisk.com Dallas, TX (PRWEB) December 21, 2012 The prescription drug resource center DrugRisk.com is alerting those patients taking the blood thinner Pradaxa that the FDA recently issued a new warning about the safety of the drug. DrugRisk has previously advised patients of conflicting safety reports and rising litigation regarding...
OTTAWA, Dec. 21, 2012 /CNW/ - The issue: Health Canada is advising health care professionals and the public that, based on new information, the blood-thinning drug Pradaxa is not to be used in patients with artificial heart valves (also known as prosthetic heart valves) due to the risk of strokes, bleeding, heart attacks, and blood clots forming on the artificial heart valves. Who is affected: Patients who are taking Pradaxa and have an artificial heart valve....
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...
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...
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....
