Spiriva May Increase Stroke Risk: FDA

Law360 (March 19, 2008, 12:00 AM EDT) -- Spiriva HandiHaler, an inhaler drug used to treat chronic breathing problems, may increase patients' risk of stroke, the U.S. Food and Drug Administration said Tuesday.

The FDA disclosed preliminary results on Tuesday from studies conducted by Spiriva manufacturer Boehringer Ingelheim Pharmaceuticals Inc. showing that the "estimated excess risk of any type of stroke due to Spiriva is two patients for each 1,000 patients using Spiriva over a one-year period."

Although the FDA's announcement pointed out that these results should be viewed with caution because it had not confirmed them, the agency said it has asked Boehringer for additional information and is...

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