It's official: drugmaker Boehringer-Ingelheim (B-I) is pleased to announce that Pradaxa (dabigatran) has been affirmed by the FDA to be more effective in preventing strokes than the old standby, warfarin (Coumadin).
It's something they are crowing about in their latest press release. The latest update to the prescribing information included with the package now assures patients that Pradaxa is “superior in reducing ischemic and hemorrhagic strokes relative to warfarin.”
The basis of this information? The RE-LY® clinical trials, the results of which were published in the prestigious New England Journal of Medicine (NEJM) – in 2009.
Before you run out to get a prescription from your doctor however, you may want to review this earlier post from May 18th - Boehringer Ingelheim UnRE-LYable. Researchers at the University of British Columbia found that the study was seriously flawed, noting that the tests were not blinded, with outcomes “subject to performance and ascertainment bias favoring dabigatran.”
The other thing that B-I's press release fails to note is that a correction was published in the NEJM the following year in which “the [RE-LY® ] study database was reevaluated for possible underreporting of events.” Nor does the press release mention that the lead researcher in the RE-LY® study had financial ties to B-I – a fact that came out this past February.
Finally, the most important facts you won't read in the B-I press release is how the drug is also Number One when it comes to adverse events. According to the Institute for Safe Medication Practices (ISMP), there were over three times the number of adverse events with Pradaxa as there were with warfarin in 2011. These events included a total of 542 fatalities for patients taking dabigatran versus 72 fatalities involving Pradaxa.
The same report noted a dramatic increase in prescription medication-related injuries and deaths overall.
In the meantime, B-I acknowledges that its product “increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding” and that there is no known reversal agent or treatment other than emergency dialysis. This hasn't appeared to slow sales, however; according to their press release, the drug “continues strong market performance 20 months after U.S. FDA approval.”
Boehringer-Ingelheim. “Superior Reduction in Ischemic and Hemorrhagic Stroke Versus Warfarin in Patients with Non-Valvular Atrial Fibrillation.” PRNewswire via Sacramento Bee, 6 June 2012.
N/A. “QuarterWatch Monitoring FDA MedWatch Reports: Anticoagulants the Leading Reported Drug Risk in 2011.” Institute for Safe Medication Practices, 31 May 2012. PDF file available at http://www.ismp.org/QuarterWatch/pdfs/2011Q4.pdf .
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