The FDA announced that data from a recent review of Spiriva HandiHaler (tiotropium dry powder for inhalation, from Boehringer Ingelheim) do not support an increased risk of stroke, heart attack, or death. This communication is based on an FDA review of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study that compared Spiriva HandiHaler with a placebo in 5,992 COPD patients. Previously, a March 2008 FDA Early Communication had described data submitted by Boehringer Ingelheim as suggesting a small increased risk of stroke in patients treated with tiotropium. In October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium.
Spiriva HandiHaler is a long-acting anticholinergic respiratory treatment indicated for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is also indicated to reduce exacerbations in COPD patients.
For more information call (800) 542-6257 or visit www.spiriva.com.