Steve Borzak, MD
Steve Borzak, MD

By Steve Borzak, MD, FACC

The British Medical Journal published several papers this week detailing concerns about the bleeding risk of pradaxa (dabigatran), a coumadin substitute used for stroke risk reduction in atrial fibrillation.  In the first article, investigative journalist Deborah Cohen describes unpublished drafts of a manuscript which was eventually published in the Journal of the American College of Cardiology in 2013 describing the bleeding profile of pradaxa.  Ms. Cohen details company concerns (in both the draft manuscript and in company emails obtained through freedom of information act applications) raising the issue of more variability in plasma levels than would be expected or desired, and the wish of the company to not provide details about this variability.  A second paper published by Thomas Moore and associates from the Institute for Save Medication Practices (a drug safety watchdog group) detail similar concerns about wide biologic variability in plasma levels and its effect on bleeding risk.
The two papers do raise the concern that potentially valuable pharmacokinetic and pharmacodynamic data was not published and could have contributed to the general knowledge base.  However, balanced conclusions about the matter appear to be the following:  1.  Neither paper offers any new data or offers substantial evidence that the bleeding risk of pradaxa is any different today compared to yesterday.  2.  Pradaxa has been subject to one of the most exhaustive postmarketing surveillance reviews ever by the FDA, and the bleeding risk after launch is identical to that published in the pivotal trial.  3.  These new papers fall under the general rubric of “bad drugs sell papers,” meaning that anything pertaining to drug safety, particularly if there can be insinuations made about a cover-up or conspiracy, draws great interest.  Bottom line: pradaxa is a safe and useful drug with a potential for harm like other anticoagulants.  Don’t stop any drug without seeing your prescribing physician.

Steve Borzak, MD, FACC
He completed a Cardiology Fellowship at the Brigham and Women’s Hospital & Harvard Medical School in Boston, MA from 1988 to 1991.
Before joining Florida Cardiology Group in 2001, Dr. Borzak was Associate Division Head of Cardiology at Henry Ford Hospital, Michigan, where he directed the Coronary Care Unit, conducted dozens of research studies and contributed extensively to cardiovascular literature. Dr. Borzak has received numerous teaching awards during his tenure, and he is currently a faculty member at Nova Southeastern College of Medicine, Fort Lauderdale, Florida.