Pradaxa Holds No Extra Bleeding Risk, FDA Says

start looking in to a matter final December.

In a review, group staff examined word claims and executive information in a supposed Mini-Sentinel beginning for reports of intracranial and gastrointestinal hemorrhage in patients starting on dabigatran or warfarin. Data from Oct 2010, when dabigatran was approved, by Dec 2011 were included.

The tender occurrence rate of such events in patients starting on dabigatran “was 1.8 to 2.6 times aloft for new users of warfarin than for new users of Pradaxa,” a FDA pronounced in a Drug Safety Communication. Event rates per 100,000 days during risk were rather aloft for intracranial draining than for gastrointestinal hemorrhage, a group said.

“The formula prove that a celebrated draining rates compared with new use of Pradaxa do not seem to be aloft than a draining rates associated

Read full article: http://www.ft.com/cms/s/2/fcb142e2-1a06-11e2-a179-00144feabdc0.html

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Source:
http://www.news.ezonearticle.com/2012/11/02/pradaxa-holds-no-extra-bleeding-risk-fda-says/