In a recent update to last year's safety warning, the U.S. Food and Drug Administration (FDA) has determined that “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.” The update adds that the information is “consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).”
There were some things about the RE-LY study that were questionable – primarily the fact (according to a letter from the University of British Columbia's Health Sciences department) that the study was not “double blinded,” and outcomes “favored” Pradaxa over warfarin. The bottom line, however: according to the most recent FDA findings, the bleeding risks of Pradaxa and warfarin are approximately equal.
Will this new information hurt plaintiffs with cases against Boehringer-Ingelheim? It shouldn't. The issue here is not about the effects of Pradaxa – which are not in dispute – but rather whether or not B.I. was aware of the fact that there is no antidote to the harmful effects of the drug. If they were aware of this fact, they had a duty to warn patients at the outset – a duty which they (allegedly) failed to carry out.
In the meantime, Pradaxa leads the parade of some 800 medications monitored by the Institute for Safe Medication Practices (ISMP) in the number of reports to the FDA involving injuries and deaths. At the same time, sales of the drug have brought in over $1 billion for the manufacturer since its introduction approximately two years ago.
What is interesting is that in early October, the ISMP reported that complaints from consumers regarding prescription drugs have risen 90% since 2008. Pradaxa and one other medication, Chantix (a medication used to help patients in overcoming nicotine addiction) account for 37% of these complaints.
FDA Drug Safety Communication: “Update On The Risk For Serious Bleeding Events With The Anticoagulant Pradaxa,” 02 November 2012. Available at http://www.fda.gov/Drugs/DrugSafety/ucm326580.htm .
Institute for Safe Medication Practices Quarter Watch Executive Summary, 3 Oct 2012. Available at http://www.ismp.org/quarterwatch/pdfs/2012Q1.pdf .
Thomas, Katie. “A Promising Drug With a Flaw.” New York Times, 2 November 2012.
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