Spiriva Linked to Possible Increased Risk for Stroke, FDA Says — Physician’s First Watch
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.