The Safety of Tiotropium — The FDA’s Conclusions | Health Policy and Reform

Perspective
The Safety of Tiotropium — The FDA’s Conclusions
NEJM | September 8, 2010 | Topics: Drugs, Devices, and the FDA

Theresa M. Michele, M.D., Simone Pinheiro, Sc.D., and Solomon Iyasu, M.D., M.P.H.

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 identified stroke, cardiovascular events, and death — which have been studied as individual or composite end points — as possible adverse outcomes.

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The Safety of Tiotropium — The FDA’s Conclusions | Health Policy and Reform