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FDA Finds No Increased Risk of MI, Stroke With Use of Tiotropium Bromide Inhalation Powder ROCKVILLE, Md -- January 14, 2010 -- The US Food and Drug Administration (FDA) has announced that data from a recent review of tiotropium bromide inhalation powder (Spiriva HandiHaler), a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, myocardial infarction (MI) or death in patients using the medicine. A March 2008 FDA Early Communication had described data submitted by the manufacturer of the tiotropium bromide inhalation powder as suggesting a small increased risk of stroke in patients treated with tiotropium. In October 2008, an Updated Early Communication highlighted 2 additional publications suggesting an increased risk of stroke, MI, and death in patients using tiotropium. Today’s update of those communications is based on an FDA review of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study, which compared tiotropium bromide inhalation powder with a placebo in 5,992 patients with COPD. In November 2009, the FDA Pulmonary - Allergy Drugs Advisory Committee also reviewed the data and voted that findings from the UPLIFT study resolved the potential safety concerns for tiotropium bromide inhalation powder. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version