UPDATE 1-Pradaxa bleeding risk appears no worse than warfarin-FDA

Fri Nov 2, 2012 2:06pm EDT

Nov 2 (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.

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Comments (4)
RN4Truth wrote:
Warfarin can be easily reversed; Pradaxa has no known medication that allows it to be reversed. As one ER doctor told me in the case of an accident (Trauma) it’s a fight to control bleeding. It’s just a matter of time… The drug is dangerous and is aggressively promoted – should the American public have to wait until there are deaths and insurance claims?

Nov 03, 2012 5:46am EDT  --  Report as abuse
paulk97 wrote:
As a long time user of Warfarin I looked forward to a replacement that would alleviate the need for frequent testing. This ain’t it, especially at the price.

Nov 03, 2012 10:06am EDT  --  Report as abuse
ghotai wrote:
As an Emergency Physician, residency trained, Board certified, with 25 years of experience, I can only say that I have had serious problems–and deaths–with pradaxa–in a fashion that I have not had with coumadin. Pradaxa is a dangerous drug that I predict will not be around in 5 years.

Nov 03, 2012 10:56am EDT  --  Report as abuse
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