We know why doctors like Pradaxa (dabigotran) it’s been pointed out in several media sources and professional journals, the number of possible harmful interactions with other medications is far less than with other anti-clotting medications, such as warfarin. This is an important issue with geriatric patients, who are often on numerous medications for a variety of age-related conditions. Doctors can simply prescribe it and not worry about constant monitoring.
There is however the issue of bleeding. A minor bump on the head can be fatal, because the mechanism by which dabigatran operates can turn the patient into a virtual hemophiliac (hemophilia is a genetic disorder in which a person's level of clotting factors are too low to allow clotting). Because dabigatran operates directly on the clotting factor (an enzyne known as thrombin), there is almost no way to stop a patient from bleeding to death outside of emergency dialysis in order to purge the patient's system of the drug.
Recently, the European Medicines Agency issued a statement reaffirming the effectiveness of dabigatran and touting it as a good alternative to the “old and problematic drug warfarin” based on a more “positive benefit-risk balance.” However, the EU agency recommends that, in light of fatal bleeding cases, package warnings be strengthened and that “...risks continue to be kept under close review.”
Among proposed changes, new advisories would warn against the use of other anti-coagulant drugs while a patient is taking dabigatran as well as guidelines for assessing patients' kidney functions.
In addition, the new guidelines would provide “for managing patients and reversing the anticoagulant effect of dabigatran if bleeding occurs.” However, it is not clear as to what these options would be, except to avoid getting bumped, bruised, scraped or cut while taking the medication. An advisory from the University of Utah Thrombosis Service clearly states that there is “currently NO reversal agent or antidote for dabigatran.” This advisory goes on to say that the use of clotting factors is “not anticipated to be wholly effective” in reversing the drug's effects, and should be used only as a last resort.
The reason of course is that while warfarin simply causes clotting factors present in the blood to run out, dabigatran prevents these clotting factors from being produced in the first place. According to the U. of U. advisory, the “primary means of reversing the effects of dabigatran is through natural renal elimination” - in other words, to allow the kidneys to do their job and get rid of the drug in the urine. Emergency dialysis may get rid of up to 60% of the drug sooner.
Unfortunately, there is as of yet no reliable drug treatment for dabigatran-related hemorrhaging.
Hughes, Sue. “Dabigatran Fatal Bleeding Less Than In Clinical Trials: New EMA Data.” Heartwire (http://www.theheart.org/article/1406229.do ), 25 May 2012.
Ganetsky, M. et. al. “Dabigatran: Review of Pharmacology and Management of Bleeding Complications on This Novel Oral Anticoagulant.” Journal of Medical Toxicology no. 7 vol. 4 (December 2011).
Grogan, Kevin. “EMA Confirms Benefits of BI's Pradaxa But Wants Clearer Guidance.” World News, 25 May 2012.
N/A. “Dabigatran ( Pradaxa® )Principles and Guidance for the Reversal of Effect and Management of Life Threatening or Major Bleeding. University of Utah Health Care Thrombosis Service. PDF file available at http://healthcare.utah.edu/thrombosis/newagents/TS.Dabi_Bleeding.pdf
Learn more about Pradaxa lawsuit