In January, the Institute for Safe Medication Practices (ISMP) released a report with their safety analysis of three anticoagulant medications, including Pradaxa, warfarin, and Xarelto. The ISMP found that approximately 1,734 adverse event reports were submitted to the U.S. Food and Drug Administration (FDA) in quarter 2 of 2012 for the anticoagulant drugs warfarin, Pradaxa, and Xarelto.
Of those adverse event reports, around 233 detail patient deaths linked to use of these three anticoagulant medications.
These numbers led the ISMP to conclude that anticoagulant medications in general pose a significant risk to patients. In fact, they found that when patients experienced a bleeding event while using Pradaxa, the likelihood of fatal Pradaxa bleeding was five times higher than that for patients using warfarin.
When combing the reports submitted over four quarters through June 30, 2012, it becomes evident that there is a serious link between the use of Pradaxa and health complications. In four quarters, 3,813 adverse event reports were submitted to the FDA for Pradaxa alone. Of those, about 654 involved patient death linked to Pradaxa use.
Though the ISMP’s analysis shows a markedly increased risk of health complications or death when using Pradaxa, upon submitting their report to Pradaxa’s manufacturer, Boehringer Ingelheim, the German pharmaceutical company asserted that one of their recent Pradaxa comparison studies demonstrated more positive results.
Boehringer Ingelheim’s unpublished study shows that patients using Pradaxa fared better compared to patients using warfarin following a bleeding event.
Despite these findings, there still exists a significant association between Pradaxa and serious bleeding events as well as death.
The ISMP conducted its analysis of adverse event reports submitted to the FDA to better understand the safety risks posed by drugs like Pradaxa and other anticoagulant medications. Their conclusion is that the numbers illustrate a grim reality, one in which Pradaxa use poses a serious threat to a patient’s health and life. In concluding its findings, the ISMP states that reasons for the serious health risks associated with Pradaxa use could be explained by the fact that Pradaxa has no reversal agent.
Such an explanation for high rates of fatality linked to Pradaxa does seem logical, since an antidote to halt excessive bleeding was never developed for Pradaxa.
Though the ISMP’s findings do not mirror those concluded in Boehringer Ingelheim’s study, it is still important to take note of the ever increasing reports submitted to the FDA alleging Pradaxa injury. Pradaxa lawyers at Carey Danis & Lowe agree that the high number of Pradaxa injury reports are a sign that further examination into the safety of this anticoagulant is absolutely necessary for public health reasons.
If you or someone you loved has been injured by Pradaxa use, contact an experienced Pradaxa lawyer at Carey Danis & Lowe. Our lawyers will provide you with a free legal evaluation about your case, and assist with filing a Pradaxa lawsuit.
Contact a Pradaxa lawyer at Carey Danis & Lowe by calling 800.721.2519 or by submitting a legal claim form.References: Pharmaceutical litigation, Pradaxa