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Bleeding Deaths From Pradaxa Five Times Higher Than From Warfarin


According to a recent review of adverse events reported to the U.S. Food and Drug Administration (FDA), bleeding problems in Pradaxa patients appear to be five times more likely to result in death than those associated with a much older anticoagulant drug, warfarin. The Institute for Safe Medication Practices (ISMP) analyzed bleeding complaint reports submitted to the FDA involving Pradaxa, warfarin and Xarelto blood thinner medications, in its latest QuarterWatch report, which includes adverse event reports from the second quarter of 2012. According to the report, the FDA received 956 adverse event complaints related to Pradaxa, with 178 of those involving the death of a patient, compared to only 214 complaints related to warfarin, 14 of which involved patient deaths. If you have experienced a life-threatening side effect that you believe to be linked to Pradaxa, consult our knowledgeable Pradaxa lawyers at Bandas Law Firm today for legal help.


According to the ISMP report, the organization conducted the comparison as a means of analyzing the possible effects of Pradaxa not having an antidote. For patients who suffer bleeding problems while taking warfarin, sold under the brand name Coumadin, vitamin K can be administered to stop the medication’s potentially life-threatening blood thinning effects. Unfortunately, there is no such reversal agent for Pradaxa bleeding problems, which may increase the risk of fatal complications. In the report, the ISMP notes that, in addition to the lack of a Pradaxa antidote, older patient age, prescribing errors and kidney problems may also play a role in the rate of Pradaxa-related deaths.

Pradaxa is an anticoagulant (blood thinner) manufactured by Boehringer Ingelheim and introduced in the United States in October 2010, and the medication is indicated for the prevention of strokes in patients with a medical condition called atrial fibrillation. Unfortunately, emerging research has suggested that, compared to patients taking other blood thinners like warfarin, Pradaxa patients may have a significantly increased risk of experiencing potentially life-threatening complications associated with the medication, including internal bleeding, heart attack, heart disease and even stroke, the very condition the drug is designed to prevent.


Approximately 200 lawsuits have already been filed against Boehringer Ingelheim on behalf of affected patients who claim that the drug firm failed to adequately warn consumers about the risk of serious or fatal side effects associated with its anticoagulant medication, and the lack of an antidote to stop bleeding problems that may occur. If you took Pradaxa and you have since suffered a bleeding problem or another major side effect like stroke or heart attack, contact our experienced attorneys at Bandas Law Firm to discuss your legal options. You may have grounds to file a drug injury lawsuit against Boehringer Ingelheim, in order to pursue financial compensation for your injuries, medical bills and other injury-related expenses.