New Study From Israel Confirms Bleeding Risks of Xarelto

Monday, January 12, 2015

A study from Israeli doctors released last month added fuel to an ongoing debate over the safety of newer style oral blood thinner drugs, noting that medications like Xarelto and Pradaxa may carry greater risks for intestinal bleeding than standby option warfarin.

The comments are just the latest data in years of conflicting evidence from manufacturers and independent researchers. On one side, German companies Bohringer Ingelheim and Bayer have touted the clinical trials behind their drugs Pradaxa and Xarelto, saying the meds carry fewer risks than warfarin.

However, some point out that these trials contain hand picked patients and dose adjust, with demographics skewed to favor positive results. In July, a British Medical Journal even suggested drug dosages were being monitored and adjusted during trials to limit dangers.

And, recent studies have concluded that the newer blood thinners may actually carry greater risks for intestinal bleeding.

The new analysis was introduced at December’s American Society of Hematology meeting in San Francisco, according to a report from MedPage Today and the American Heart Association.

There, Dr. Martin H. Ellis, chair of Israel's Hematology and Blood Bank Institute at Tel Aviv University, discussed his teams review of records from nearly 18,250 patients who had started Coumadin, Xarelto or Pradaxa from 2011 through 2013.

Among their findings were that Xarelto and Pradaxa may have similar overall risks for major internal bleeding episodes, while having fewer risks for intracranial internal bleeding. However, risks for gastrointestinal internal bleeding were slightly higher with those taking the new anticoagulants instead of warfarin.

Ellis pointed out the merits of studying the drugs in a real-world setting, instead of a controlled clinical trial where only select patients are included to affect the outcome.

Both Pradaxa and Xarelto have faced heated litigation in the U.S. from patients suffering internal bleeding, or from families who’ve lost a loved one. Last year, around 4,000 Pradaxa cases were settled for $650 million.

This year, a growing number of Xarelto lawsuits were consolidated to a federal multidistrict court in Louisiana.

Check back with DrugNews for more on blood thinner drug safety and litigation.

 

Sources:

Phend, C.  Stroke Rounds: NOAC Bleeding Risks as Expected in Practice. MedPage Today. (December 9, 2014). Retrieved from http://www.medpagetoday.com/Cardiology/Arrhythmias/49012

Phend, C. Monitoring, Dose Adjustment for Pradaxa? MedPage Today. (July 23, 2014). Retrieved from http://www.medpagetoday.com/Cardiology/Arrhythmias/46901

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