Early warning of Spiriva’s potential stroke risk
March 24, 2008
The long-term maintenance treatment of COPD with Spiriva HandiHaler, containing tiotropium bromide, may be associated with an increased risk of stroke. An Early Communication has been issued by the Food & Drug Administration that warns of a potential increased risk of stroke in patients using the inhaler. The manufacturer reported to the agency a preliminary estimate that the risk of stroke during clinical trials is eight patients per 1,000 patients treated for one year with tiotropium and six patients per 1,000 patients treated with placebo for the same amount of time. The resulting risk of any type of stroke due to the inhaler appears to be two patients for every 1,000 using the inhaler for a year. The FDA cautioned practitioners that the findings are only preliminary and no regulatory action is being taken at this time. The agency will further evaluate postmarketing adverse event reports and will review data from the company’s UPLIFT study, a large four-year study that will provide additional long-term safety data. The results are due out in June. At that time the FDA will analyze the new information and communicate its conclusions.Article Via: Drug Topics, by By: Heidi Belden, Pharm.D.
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