Quoted from http://www.bloomberg.com/news/2011-06-14/boehringer-pfizer-s-spiriva-may-raise-death-risk-study-finds.html
Pfizer-Boehringer’s Spiriva May Raise Death Risk, Analysis of Studies SaysBy Dermot Doherty - Jun 14, 2011 6:30 PM ET
Boehringer Ingelheim GmbH and Pfizer Inc. (PFE)’s Spiriva mist inhaler for chronic lung disease may raise the risk of an early death, a review of five studies found.
The use of Spiriva administered in mist form was associated with a 52 percent increase in the risk of mortality, compared with patients given only a placebo, according to the review published today in the British Medical Journal. The analysis included five clinical trials involving more than 6,500 patients.
“The findings add weight to recent safety concerns by regulatory agencies regarding the risk of an increased mortality risk associated with this device,” the BMJ said in a statement.
The U.S. Food and Drug Administration last year said a two- year review didn’t indicate Spiriva increased the risk of heart attack and stroke. Earlier studies had suggsted a potential risk. Spiriva is a long-acting treatment for chronic obstructive pulmonary disease, a breathing difficulty that affects as many as 24 million Americans, according to the National Heart, Lung and Blood Institute, a U.S. agency. The medicine is co-marketed by New York-based Pfizer and closely held Boehringer, of Ingelheim, Germany.
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