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Pradaxa Heart, Bleeding Side Effects Raising Concerns

Mar 28, 2012 | Parker Waichman LLP

Since late last year, concerns about Pradaxa’s heart and bleeding side effects have grown, leading some to question whether its risks outweigh its benefits.  Pradaxa was approved by the U.S. Food & Drug Administration (FDA) in 2010, and was expected to replace warfarin, a decades-old anti-clotting drug.

"What we've seen is that the amount of people having death from hemorrhagic events in the brain is higher than expected," epidemiologist Adrian Hernandez recently told the Cleveland Plain Dealer. "That's another part that's being played out now as part of this risk-benefit."

According to the Plain Dealer, Hernandez worked on a study published in the Archives of Internal Medicine in January, which pooled data from six smaller Pradaxa trials.  The study   found that patients in the Pradaxa groups had a 33 percent increased chance of having a heart attack.  Overall, there were there were 237 coronary events among the 20,000 combined trial participants taking Pradaxa compared with 83 of 10,514 taking warfarin, the Plain Dealer said.

Earlier this month, bleeding risks associate with Pradaxa were highlighted by an article published in the Journal of Neurosurgery that detailed the death of an 83-year-old Pradaxa patient from a brain bleed that followed a minor fall.   Many of the patients who take Pradaxa are elderly, and such falls are common with this population.

Last year, Boehringer Ingelheim acknowledged that since March 2008, it had received 260 reports of bleeding-related deaths in patients taking Pradaxa. The FDA launched a review of Pradaxa in December over reports of bleeding-related side effects. Regulators in Europe and Japan have also directed Boehringer Ingelheim to strengthen warnings for the Pradaxa.

Bleeding is a common side effect of all blood thinners, including warfarin. However, warfarin bleeding can be stopped with the administration of vitamin K, but there is no similar antidote for Pradaxa bleeding. 

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