As of December 2013, the U.S. Food & Drug Administration (FDA) has planned a large scale-assessment to compare the bleeding rates of the anti-stroke drug Pradaxa to those associated with Coumadin. The announcement comes as thousands of lawsuits alleging that use of the drug may cause life-threatening episodes of internal bleeding move through U.S. courts. According to a notice posted on the FDA website on December 30, 2013, the new Pradaxa study will examine selected safety outcomes in adults with atrial fibrillation (AFib) who are new users of dabigatran or warfarin, generics of Pradaxa and Coumadin.
First introduced in 2010 as an effective warfarin alternative, Pradaxa is meant to prevent strokes in atrial fibrillation patients. Both of these drugs are blood thinners meant to keep new blood clots from forming and stop existing blood clots from getting bigger. Late last year, it was reported that the FDA received approximately 3,300 notifications of adverse Pradaxa side effects in 2012, more than any other drug it monitors. Most of the reports involved cases of internal bleeding and hundreds of cases proved fatal. Whereas warfarin side effect reports resulted in a fatal outcome just 6.5% of the time that year, Pradaxa’s rate was about 18%.
According to court documents, at least 2,100 Pradaxa lawsuits have been filed so far. Obviously, that number is still far less than the number of victims affected by this drug and therefore many more lawsuits are expected in the days ahead. The existing lawsuits say that Pradaxa was improperly marketed as a safe alternative to warfarin, an anti-stroke medicine that has been widely prescribed since the 1950s. Pradaxa lawsuits further allege that the manufacturer of Pradaxa failed to disclose its risk and the severity of potential Pradaxa bleeding.
According to the New York Times:
“The one-size-fits-all was a mistake for a drug with this kind of risk,” said Thomas J. Moore, a senior scientist at the Institute for Safe Medication Practices, which keeps track of safety reports submitted to the F.D.A. He rated anticoagulants — including warfarin and Pradaxa — as the most serious safety problem in 2011 and 2012. He said Pradaxa has been cited in more than 1,000 deaths reported to the agency through the end of 2012.
The Pradaxa lawyers at Childers, Schlueter & Smith, LLC plan on keeping you informed on the FDA findings as well as the lawsuits currently filed against the drug’s makers. The Federal Court faced with the lawsuits has already taken considerable legal action though the official trials are not set to begin until August 2014. For now, if either you or a love one is using Pradaxa to treat atrial fibrillation, and experienced an uncontrolled bleeding event, we invite you to give us a call to explore your legal options.