The Pharmaceutical Journal
Vol 280 No 7496 p389
5 April 2008

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News summary

FDA looks at possible increased stroke risk with tiotropium

A possible increased risk of stroke in patients using tiotropium is being investigated by the US Food and Drug Administration.

Boehringer Ingelheim recently informed the FDA that an analysis of safety data from 29 studies involving patients treated with Spiriva HandiHaler and Spiriva Respimat suggested that two patients in every 1,000 treated with tiotropium for one year would experience a stroke who would not have done had they received placebo.

The FDA stated that it is not advising health care professionals to stop prescribing these products.