by Steve S. Ryan, PhD, April 15, 2013; Updated October 2015
We’ve been reading heart-wrenching stories of people on Pradaxa bleeding to death in Emergency Rooms because there’s no antidote to reverse its blood-thinning effects. Pradaxa was identified as the primary suspect in 542 patient deaths reported to the FDA in 2011, as well as 3,781 serious adverse events. Pradaxa “was linked to more reports of injury and death than any of the more than 800 drugs regularly monitored by the Institute for Safe Medication Practices.” By comparison, warfarin (Coumadin) was associated with only 72 deaths during that same time period.
People taking Pradaxa were almost 5 times as likely to die from bleeding episodes than those taking warfarin.
Dr. Bryan A. Cotton, a trauma surgeon at Memorial Hermann-Texas Medical Center in Houston has said Pradaxa contributed to the bleeding deaths of at least eight patients at his hospital.
What a horrible way to die. Doctors and nurses in the ER try everything they can think of, but then have to watch as their patient dies from uncontrolled bleeding. How devastating for relatives and friends.
Why in the world would the FDA put blood thinners on the market that have no antidote or reversal agent, where people die because their bleeding can’t be stopped? Warfarin may not be perfect, but ER doctors at least have a fighting chance to stop someone from bleeding to death if they are taking warfarin.
Some doctors who receive consulting fees, etc. from Boehringer Ingelheim (the manufacturer of Pradaxa) are arguing that there was no evidence that the lack of an antidote contributed to the deaths of the Pradaxa takers who bled to death. (Try telling that to the ER doctors who had to watch their patients die from uncontrolled bleeding.)
Another argument is that 542 deaths is a small number compared to the number of people using Pradaxa. But many of these 542 deaths did not have to happen. Many deaths could probably have been prevented if there was a reversal agent like there is with warfarin.
We can’t expect the FDA to take Pradaxa off of the market or put any significant limits or safeguards on its use any time soon. The FDA tends to stand by any drug it approves. It’s embarrassing to them to admit they were wrong. (Some people go so far as to say the Drug Industry has a great deal of influence over the FDA.)
The solution is simple: Stop Prescribing or Taking Pradaxa. Go back to warfarin which isn’t as convenient as the new anticoagulants. But warfarin does work reasonably well if you stay in the proper INR range. And it does have reversal agents.
And there are alternatives to Pradaxa besides warfarin. The FDA has approved the anticoagulants Rivaroxaban (Xarelto) from Bayer & Johnson and Johnson and Apixaban (Eliquis) from Bristol-Meyers Squibb & Pfizer. However, “a European study also showed new blood thinners like Pradaxa can have 55% higher risks for internal bleeding.”
While these new anticoagulants also don’t have reversal agents, there is anecdotal evidence that Xarelto has fewer bleeding deaths than Pradaxa. The recently approved Eliquis tested better and is safer.
Update October 26, 2015: FDA Approves Reversal Agent for Pradaxa (dabigatran)
In a new study of 90 patients who had uncontrolled bleeding with Pradaxa, Praxbind (idarucizumad) stopped this bleeding within minutes. No serious side effects were reported.
We have previously reported on the reversal agent Andexanet Alfa which is on FDA fast track approval as an antidote to the Factor Xa inhibitors Xarelto and Eliquis. FDA approval is pending.
[su_spoiler title=”References for this article”]Thomas, Katie. “A Promising Drug with a Flaw” The New York Times, Business Day, November 2, 2012. Last accessed April 16, 2013. URL: http://tinyurl.com/NYT-bleeding-deathsWarriner, Cal.
“The Debate Over Pradaxa (Dabigatran) Safety – Follow the Money” The Legal Examiner, West Palm Beach, Florida, March 20, 2012.
Schroeder, Chris. Amid Rising Injuries and Lawsuits, FDA Orders New Study of Pradaxa Bleeding, DrugNews.net. Saturday, January 11, 2014. http://www.drugnews.net/news/amid-rising-injuries-lawsuits-fda-orders-new-study-pradaxa-bleeding
Marzo, Kevin. Blood thinner Antidote. Bottom Line Health, Volume 29, Number 9, September 2015, p. 1.Mundell, E.J.. Drug May Be Antidote to Bleeding Tied to Blood Thinner Pradaxa. Medline Plus. Monday, June 22, 2015. http://www.nlm.nih.gov/medlineplus/news/fullstory_153206.html
Must-read: marketing vs. medicine in the case of Pradaxa (dabigatran). The Poison Review. July 27, 2014. http://www.thepoisonreview.com/2014/07/27/must-read-marketing-vs-medicine-in-the-case-of-pradaxa-dabigatran/[/su_spoiler]
[lastupdated format=”l, F j, Y”]