A new report issued by the Institute of Safe Medication Practices warns doctors and patients about the life-threatening side effects potentially associated with the blood thinner Pradaxa.
According to the findings of a new drug safety report, the controversial blood thinner Pradaxa continued to lead all other medications in adverse event reports submitted to the U.S. Food and Drug Administration (FDA) in 2012, including reports of internal bleeding and deaths. This is the second year Pradaxa has topped the list of more than 700 medications being monitored by the Institute for Safety Medication Practices (ISMP), which is distressing, considering the anticoagulant has only been on the market in the United States for two full years. If you took Pradaxa to reduce your risk of stroke and you have since suffered a major side effect like internal bleeding, our consumer advocates at the Consumer Justice Foundation can help put you in touch with an attorney in your area who has experience handling product liability claims involving Pradaxa.
Pradaxa (dabigatran) was introduced by drug maker Boehringer Ingelheim in October 2010, and was the first of a new class of blood thinners touted as a superior alternative to warfarin for stroke prevention. According to the drug company, among the benefits of Pradaxa is that the drug is easier to take than warfarin and requires less medical monitoring. However, serious concerns have been raised about the safety of Pradaxa in recent years. According to an analysis conducted by ISMP, the FDA’s Adverse Event Reporting System received at least 3,292 reports during 2012 that involved problems associated with Pradaxa side effects, including least 582 deaths. Comparatively, warfarin was only named in 861 adverse event reports in 2012, including 56 deaths. The most common adverse event identified among warfarin and Pradaxa users was hemorrhaging, or uncontrolled bleeding.
A major concern involving Pradaxa side effects is that, while bleeding events associated with warfarin can be countered with a dose of Vitamin K, there is no known antidote, or reversal agent, for Pradaxa. Despite claims by Boehringer Ingelheim that Pradaxa is just as safe, if not safer, than warfarin, the recent ISMP report found that Pradaxa side effects were more likely to result in patient death than warfarin side effects. According to the analysis, 18% of adverse events among Pradaxa users resulted in death, compared to only 6.5% of warfarin adverse events.
In addition to examining the risk of bleeding side effects associated with Pradaxa, the ISMP report also took to task the FDA’s handling of Pradaxa, claiming that the agency has “apparently intended to discount safety concerns” linked to the blood thinner. “The agency took several additional actions to reassure doctors and patients that a growing number of adverse event reports did not signal an important risk,” the report claims. “The FDA’s many actions to discount mounting safety concerns about anticoagulant adverse effects remain unexplained.”
In light of the potential risk of side effects associated with the relatively new anticoagulant, hundreds of Pradaxa lawsuits are currently pending in state and federal courts throughout the United States, filed on behalf of former patients who suffered severe and sometimes even fatal injuries. The complaints allege that Boehringer Ingelheim failed to adequately warn patients about the bleeding risk associated with Pradaxa, or about the lack of a reversal agent. If you or a loved one has suffered a major side effect like hemorrhaging, and you believe a potentially dangerous medication like blood thinner Pradaxa to be the cause, contact a reputable lawyer in your area for legal help. With a product liability attorney on your side, you may be able to pursue financial compensation for your injuries and medical bills.
[box type=”note” align=”aligncenter” ]Source: http://www.ismp.org/QuarterWatch/pdfs/2012Q4.pdf[/box]
