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By: Irvin Jackson | Published: May 1st, 2012
A wrongful death lawsuit has been filed against Boehringer Ingelheim on behalf of a Tennessee woman who bled to death, allegedly due to side effects of Pradaxa.
The Pradaxa lawsuit was filed last month in the U.S. District Court for the Western District of Tennessee by Marlene Wright, on behalf of the Estate of Gertrude Eubanks, who died from internal bleeding on April 4, 2011, just days after she started using the relatively new anticoagulant.
Pradaxa (dabigitran) was introduced by Boehringer Ingelheim in the United States in October 2010, as an alternative to Coumadin (warfarin) for prevention of strokes among individuals with atrial fibrillation.
Although the medication was promoted as easier to use than warfarin, because it requires less monitoring, Pradaxa does not have a reversal agent that can be used to quickly stop bleeding problems that may develop. With warfarin, doctors can give patients a dose of vitamin K if bleeding problems occur, but no such antidote is available for Pradaxa users.
According to the complaint (PDF), Eubanks began to bleed internally within days of when she started using Pradaxa. Because there is no antidote available, Wright alleges that Eubanks bled to death from Pradaxa, after her doctors were unable to stop the bleeding.
In recent months, concerns have increased about the Pradaxa bleeding risk, as hundreds of adverse event reports have been filed with the FDA involving hemorrhages and internal bleeding, which have caused many users to bleed to death due to the lack of a reversal agent.
According to a report released by the Institute for Safe Medication Practices in January 2012, more instances of bleeding problems with Pradaxa were reported to the FDA during the first quarter of 2011 than were reported in association with any other drug monitored by the group. At least 505 instances involving Pradaxa bleeding events were reported, compared to 176 cases reported with warfarin, which was second on the list.
Pradaxa safety investigations are now underway in the U.S. by the FDA, as well as in the European Union and Canada.
A growing number of similar Pradaxa lawsuits have been filed in state and federal courts throughout the United States in recent months. The complaints allege that Boehringer Ingelheim failed to adequately research their medication and promoted the medication as an alternative to the older, safer anticoagulant warfarin, even though they failed to provide adequate warnings about the lack of a reversal agent.