FDA Rethinks Spiriva Stroke Warning

Spiriva Inhaler Not Linked to Stroke, New Study Suggests

From the WebMD Archives

Oct. 9, 2008 – The FDA is reconsidering its recent warning that the lung disease drug Spiriva might raise stroke risk.

The warning came after Spiriva maker Boehringer Ingelheim analyzed pooled data from 29 Spiriva studies. These studies suggested that for every 1,000 patients taking Spiriva, there were two extra cases of stroke.

Now there's new data from the four-year UPLIFT study of some 6,000 patients with chronic obstructive pulmonary disease (COPD). The patients -- average age 65 -- took Spiriva or placebo in addition to other types of respiratory drugs.

There were 82 strokes among the 2,987 patients taking Spiriva and 80 strokes among the 3,006 patients getting an inactive placebo. The difference is not statistically significant.

The FDA says it will take several months for it to finish it's review of the huge amount of data from the UPLIFT study. At that time, the federal agency says it will release all existing data on Spiriva and stroke risk.

WebMD Health News Reviewed by Louise Chang, MD on October 09, 2008

Sources

SOURCES:

FDA: "Early Communication about an Ongoing Safety Review of Tiotropium (marketd as Spiriva HandiHaler), Oct. 9, 2008.

Tashkin, D.P. The  New England Journal of Medicine, Oct. 9, 2008; vol 359: pp 1543-1554.

WebMD Health News: "Spiriva Eases Lung Disease Symptoms."

WebMD Health News: "FDA Checking on Spiriva and Stroke."

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