Quoted from http://www.reuters.com/article/2011/11/02/boehringer-pradaxa-idUSL5E7M21TB20111102
Boehringer says about 50 deaths related to Pradaxa
FRANKFURT, Nov. 2 | Wed Nov 2, 2011 8:07am EDT
FRANKFURT, Nov. 2 (Reuters) - Boehringer Ingelheim's new stroke prevention pill Pradaxa has been linked to about 50 deaths from bleeding across the world since its market launch, the company said on Wednesday, heightening health regulators' attention.
"Fifty cases is a reasonable order of magnitude that has emerged so far," a company spokesman told Reuters on Wednesday, adding that the number of deaths was within expectations from the clinical study that led to its market approval.
Pradaxa, an anti-clotting pill, won regulatory clearance in the United States for stroke prevention in October 2010, followed by other important markets this year.
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