Again In 2012, Pradaxa (Dabigatran) Had Dubious Distinction Of Being Ranked First For Direct FDA Reports Of Adverse Events
SUMMARY: As regards Pradaxa, we get this disturbing fact from the October 2013 edition of ISMP QuarterWatch, Data from 2012 Quarter 4 and Annual Report:
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.
And 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.
We will continue to monitor the safety profile of Pradaxa.[Read this article in full at original source]