Follow-Up to the October 2008 Updated Early Communication About an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)
[01-14-2010] This is a follow-up to previous Early Communications issued in 2008 by the US Food and Drug Administration (FDA) describing a potential increase in the risk of stroke, heart attack, or death from a cardiovascular cause related to the use of tiotropium, which is marketed as Spiriva HandiHaler. The FDA has now completed its review and believes the available data do not support an association between the use of the Spiriva HandiHaler and an increased risk for these serious adverse events.
The FDA is advising health-care professionals to continue to prescribe the Spiriva HandiHaler as recommended in the drug label.
The Spiriva HandiHaler is a long-acting respiratory medication used for the treatment of chronic obstructive pulmonary disease (COPD). Consumers currently using the Spiriva HandiHaler should talk to their health-care professional if they have any questions or concerns about the use of this medication.
