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pradaxa_logo 150 pix 96 res

One of the new NOACs for stroke risk in A-Fib patients

Claim “Misguided” That Pradaxa Needs No Blood-Level Monitoring

According to Dr. Thomas J. Moore, senior scientist at the Institute for Safe Medical Practices, the claim that Pradaxa needs no blood-level monitoring is “misguided.” “It turns out the company has had data for several years, showing the amount of anticoagulation varied [from patient to patient] more than five-fold.” The same dose could produce an extremely high risk of bleeding in some patients, while others wouldn’t get a strong enough blood clotting effect.

PRADAXA NOT SAFE TO USE WITHOUT MONITORING PLASMA LEVELS

In an editorial in BMJ, Dr. Rita Redberg, MD, a professor of medicine at the University of California, San Francisco wrote, “The concerns are that Pradaxa was approved on the basis that it did not require monitoring. There is now new evidence…suggesting it is not safe to use it without monitoring, particularly in the elderly and those with kidney disease. The bleeding risk is higher than we first thought, and the effectiveness is basically equivalent to warfarin.”

The researchers said that up to 40% of all deaths and serious bleeding events related to Pradaxa could have been avoided by simple blood testing.

BOEHRINGER-INGELHEIM WITHHELD DATA ON PRADAXA

According to several articles in the British Medical Journal, “Boehringer-Ingelheim withheld important data from regulators regarding the safety of Pradaxa as the drug was under review for approval…The company didn’t share its own analysis…suggesting a steep drop in bleeding risk when Pradaxa was dosed with guidance from plasma-level monitoring.”

In an article by ABC News: “A scientific study…suggests the makers of Pradaxa may have held back information that may have prevented serious bleeding complications among some of the million or so Americans using it.” This would have undermined the key marketing message that no such monitoring is needed, as there is for INR monitoring for warfarin.

Pradaxa (dabigatran by Boehringer-Ingelheim) has been associated with tragic bleeding deaths (see Stop Prescribing or Taking Pradaxa: Suspect in 542 Patient Deaths and Pradaxa Litigation Update May 2014)

 “Anticoagulation treatment for people with A-Fib ranks as one of the highest risk treatments in older Americans.”

Editor’s Comments:
The average Cardiologist prescribing Pradaxa isn’t prepared to (or even interested in) monitoring plasma levels of Pradaxa. They don’t know what exactly the correct level is. But, as Dr. Thomas Moore above states, “Anticoagulation treatment for people with A-Fib ranks as one of the highest risk treatment in older Americans…More than 15% of older patients treated with blood thinners for one year have bleeding.” 
This is yet another reason to stay away from Pradaxa. If your doctor prescribes Pradaxa, get them to switch to Eliquis (which tested the best and is the safest new anticoagulant), Xarelto or go back to warfarin. If not, then find another doctor. (Thanks to Barry Schwartz for calling our attention to these articles.)

REFERENCES:

Stiles, Steve. BMJ Reports Blast Pradaxa’s Path to Market, Make Push for Dose Monitoring. Medscape. July 23, 2014. http://www.medscape.com/viewarticle/828750

Doheney, Kathleen. Blood-Thinner Pradaxa: What You Should Know. WebMD Health News July 25, 2014. http://www.webmd.com/stroke/news/20140725/blood-thinner-pradaxa

Kamath, Suneel. Report Raises Safety Question on Popular Blood Thinner. ABC News. July 25, 2014. http://abcnews.go.com/blogs/health/2014/07/25/report-raises-safety-questions-on-popular-blood-thinner/

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

Mandrola, J. Getting the dabigatran (Pradaxa) story right… Correcting four common mistakes. August 21, 2014 

 

 

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