Study warns of excess bleeding risk with Pradaxa
A new study published in the New England Journal of Medicine warns that the lack of an effective treatment for severe bleeding caused by Pradaxa may put the lives of patients taking the drug at risk. The study by researchers at the Haematology Society of Australia and New Zealand examined the cases of dozens of patients who experienced excess bleeding after taking Pradaxa.
In a letter to the editor published along with the results of their study, researchers warned about the danger posed by the lack of an antidote for patients who experience Pradaxa side effects. Unlike warfarin (Coumadin), another anticoagulant drug, patients who are being treated with Pradaxa cannot be given a reversal agent to halt the anticoagulant effects of the drug and stop severe bleeding.
The Food and Drug Administration launched an investigation into the side effects of Pradaxa in December 2011 after receiving dozens of reports of excess bleeding among patients taking the drug. Although Pradaxa lawsuits have been filed by patients who were injured after taking the drug, the FDA has not announced any plans to issue a Pradaxa recall.