The Safety of Tiotropium - The FDA's Conclusions.
N Engl J Med. 2010 Sep 16;363(12):1097-1099
Authors: Michele TM, Pinheiro S, Iyasu S
Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide, and the rate of COPD-related death is increasing.(1) No current drug therapy alters the progressive decline in lung function that characterizes this disease. In 2004, the Food and Drug Administration (FDA) approved the use of tiotropium delivered by the HandiHaler device, the first long-acting anticholinergic bronchodilator for treatment of COPD. Trials supporting tiotropium's approval demonstrated sustained bronchodilation over a 24-hour period. More recent studies have shown that treatment with the tiotropium HandiHaler reduces COPD exacerbations. Concerns have been raised, however, about tiotropium's safety. In particular, disparate sources have .Â .Â .
PMID: 20843240 [PubMed - as supplied by publisher]