In the midst of concerns about the risk of internal bleeding side effects linked to the anticoagulant Pradaxa, a review of adverse event reports submitted to the FDA indicates that fatal bleeding problems appear to be five times more likely in Pradaxa patients compared to those taking the much older blood thinner warfarin. Pradaxa (dabigitran) is an anticoagulant medication introduced by drug maker Boehringer Ingelheim in October 2010 as a method of stroke prevention in patients with a medical condition called atrial fibrillation. Unfortunately, mounting research has indicated that Pradaxa patients may actually have an increased risk of stroke, heart attack and internal bleeding side effects than patients taking other blood thinners, like warfarin. If you took Pradaxa and you have since suffered a major side effect, contact our experienced attorneys at AMA Law today to discuss your legal options.
Fatal Bleeding Events With Pradaxa Use
In its latest QuarterWatch report, the Institute for Safe Medication Practices (ISMP) analyzed complaints reported to the U.S. Food and Drug Administration (FDA) during the second quarter of 2012, involving various anticoagulant (blood thinner) medications. The analysis looked at reports of bleeding complications submitted by patients and doctors that were associated with the use of Pradaxa, warfarin and Xarelto. According to the ISMP report, Pradaxa was linked to 956 complaints of adverse events, including 178 reports of patient deaths. Warfarin, on the other hand, was linked to only 214 complaints, 14 of which involved the death of a patient.
Lack of a Pradaxa Reversal Agent
According to the ISMP, the analysis was conducted in an effort to examine the possible adverse effects of the Pradaxa blood thinner not having a reversal agent. For patients taking the anticoagulant warfarin, sold under brand name Coumadin, a doctor can administer vitamin K to stop the medication’s blood thinning effects in the event of a bleeding problem. There is no such 1 / 2Internal Bleeding Deaths Five Times More Likely With Pradaxa Than Warfarin antidote for internal bleeding side effects in patients taking the anticoagulant Pradaxa, which may increase the risk of these patients suffering fatal complications. The ISMP report also notes that a New Zealand study found that, in addition to the lack of a reversal agent, kidney problems, prescribing errors and older patient age may also play a role in the incidence of Pradaxa deaths.
Contact Our Attorneys to File a Claim
Information linking Pradaxa to devastating side effects is not new. Approximately 200 lawsuits have already been filed against Boehringer Ingelheim on behalf of Pradaxa patients who have experienced serious bleeding side effects linked to the drug. The complaints allege that the drug company failed to adequately warn patients and the medical community about the risk of serious or fatal reactions to the blood thinner, and the lack of an antidote to stop bleeding problems that may develop. If you have experienced a major internal bleeding event that you believe to be associated with Pradaxa, consult our reputable lawyers at AMA Law to explore your compensation options. You may have grounds to file a drug injury lawsuit against Boehringer Ingelheim, in order to pursue financial compensation for your injuries and medical expenses.