Again In 2012, Pradaxa (Dabigatran) Had Dubious Distinction Of Being Ranked First For Direct FDA Reports Of Adverse Events
The October 2013 edition of ISMP QuarterWatch, Data from 2012 Quarter 4 and Annual Report, let us know that adverse drug events (ADEs) reports submitted directly to the FDA by consumers or patients and health professionals identified two anticoagulants, Pradaxa (dabigatran) and Coumadin (warfarin), as the most frequent suspect drugs for the year.
As regards Pradaxa, in particular, we get these rather interesting facts from this latest edition of the well-regarded ISMP QuarterWatch publication:
- As in our previous analysis, reported [Pradaxa (dabigatran)] adverse event cases were more likely to result in death, accounting for 18% of cases, compared to 6.5% deaths for warfarin and 7.2% for rivaroxaban.
- The agency took several additional actions to reassure doctors and patients that growing number of adverse event reports did not signal an important risk....
- ... in November 2012, saying that a new study in insurance claims data and electronic health records indicated “bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin.” However, the drug safety communication announcement provided few details about the actual study, omitting major facts such as how many cases it had actually examined....
- ... in April of 2013 when the FDA Office Director who had initially approved [Pradaxa (dabigatran)] -- Ellis F. Unger -- wrote a “Perspective” article in the New England Journal of Medicine, discounting the postmarketing reports, summarizing the unpublished study in electronic health records, and concluding, “We believe that [Pradaxa (dabigatran)] provides an important health benefit when used as directed.” In this unusual editorial the FDA did not reveal how many adverse event reports it had received about [Pradaxa (dabigatran)] or warfarin, but nevertheless dismissed them, saying “the large number of reported cases of bleeding provides a salient example of stimulated reporting.” However, the health insurance and medical record data on which the FDA had relied proved to be unusually sparse.
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And, last but not least, the October 2013 QuarterWatch article points out this rather strange FDA action as regards Pradaxa:
In April 2013, the FDA required an unusual Boxed Warning -- normally an alert to a dire drug risk -- stating that stopping the drug might increase the risk of stroke, but neglecting to mention that stopping [Pradaxa (dabigatran)] would also reduce the risk of severe hemorrhage.
But then again, perhaps that "unususual Black Box" is not so strange, given that:
The FDA actions since [Pradaxa (dabigatran)] was approved in 2010 have been almost entirely supportive of [Pradaxa (dabigatran)] and apparently intended to discount safety concerns.
We commend the QuarterWatch Project Team -- Thomas J. Moore, Michael R. Cohen, Curt D. Furberg, and Donald R. Mattison -- for putting this spotlight on the FDA as regards the still-emerging drug safety issue concerning Pradaxa and serious bleeding events.