Boehringer Ingelheim has informed the FDA of a possible increased risk of stroke in patients taking Spiriva HandiHaler (tiotropium bromide inhalation powder). Safety data from 29 placebo-controlled clinical studies revealed that preliminary estimates of stroke risk are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. The FDA has not confirmed these analyses but is working with Boehringer Ingelheim to further evaluate these findings.

Spiriva is indicated for the long-term maintenance treatment of bronchospasm due to chronic bronchitis and emphysema.

For more information visit www.fda.gov/cder/drug/early_comm/tiotropium.htm.