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Spiriva Linked to Possible Increased Risk for Stroke, FDA Says
Spiriva HandiHaler (tiotropium bromide), used for treating COPD-associated bronchospasm, may increase the risk for stroke, the FDA says in an early communication.
The manufacturer told the FDA that in 29 placebo-controlled studies, the estimated risk for stroke was 8 cases per 1000 patients treated for 1 year with Spiriva, compared with 6 cases per 1000 receiving a placebo.
The manufacturer, Boehringer Ingelheim, expects safety data from a large, 4-year study to be available in June. The FDA says it will make its recommendations once it has analyzed that data.
FDA alert (Free)
Wall Street Journal story (Free)
Published in Physician's First Watch March 19, 2008
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