Pradaxa bleeding risk appears no worse than warfarin - FDA

Fri Nov 2, 2012 2:08pm EDT

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(Reuters) - The risk of serious bleeding among new users of Pradaxa, a blood-clot preventer made by Germany's Boehringer Ingelheim, appeared to be no higher than in patients on the widely used standard blood thinner warfarin, U.S. regulators said.

The announcement Friday by the U.S. Food and Drug Administration may allay some safety concerns about Pradaxa, a pill developed by the privately held drugmaker Boehringer, to prevent strokes among patients with an irregular heartbeat known as atrial fibrillation.

The regulator's findings were based on an assessment of insurance claims and other data.

Over the past year, the FDA has been analyzing reports of serious bleeding among patients prescribed Pradaxa, including gastrointestinal bleeding and bleeding in the brain.

The agency said on Friday a comparable risk of serious bleeding for Pradaxa and warfarin was suggested by its review of insurance claims and by analyzing electronic healthcare data from multiple other sources.

The FDA said it was also planning other assessments of Pradaxa's bleeding risks.

The medicine competes with Xarelto, a stroke-prevention pill for atrial fibrillation patients developed by Johnson & Johnson and Bayer AG.

A similar pill being developed by Bristol-Myers Squibb and Pfizer Inc, Eliquis, is awaiting U.S. approval and is deemed by many Wall Street analysts to be the most impressive of a new generation of oral drugs to replace warfarin.

(Reporting by Ransdell Pierson in New York; Editing by Bernadette Baum)

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Comments (2)
ghotai wrote:
Well, the announcement does not reflect the experience of the medical community with Pradaxa. As a seasoned (25 years), residency trained and board certified emergency medicine physician, Pradaxa has been a drug which has led to patient deaths and been a nightmare to manage. With no EFFECTIVE reversal (unlike coumadin), when you get into trouble, you are in deep trouble. I predict that Pradaxa will not be around in 5 years.

Nov 03, 2012 1:31pm EDT  --  Report as abuse
wsp wrote:
One problem….NO ANTIDOTE!!!… Apparently only ER physicians are aware and have seen firsthand the effects of this. Imagine telling the patient’s family there is nothing you can do to
reverse this and the patient will ultimately bleed out and die…..over 470 deaths this year related to an overdose. Managing coumadin for each patient is both art and science (especially with the elderly in LTC facilities), but if a mistake is made, vit. K is readily available…..

Nov 04, 2012 12:08pm EST  --  Report as abuse
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