Spiriva HandiHaler, which is Boehringer Ingelheim’s respiratory drug, may actually increase the risk of stroke. Spiriva was associated with two more cases of stroke in every 1,000 patients treated for one year compared with a placebo medicine in a pooled analysis of 13,500 patients, according to a notice posted last month on the FDA’s Web site. The agency is still reviewing the available data and hasn’t confirmed an increased risk. Boehringer, the world’s largest family-owned drug maker, markets Spiriva in the U.S. with Pfizer Inc. as a once-a-day inhaled treatment for breathing difficulty caused by chronic obstructive pulmonary disease. The Ingelheim, Germany-based company is assessing the long-term effects of the drug in a four-year study that is expected to report results in June, according to the FDA. The FDA plans to analyze the new study, called Uplift, and make conclusions and recommendations to the public.
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