Pfizer/Boehringer Ingelheim’s Spiriva Linked To Stroke In FDA MedWatch Alert
This article was originally published in The Pink Sheet Daily
Executive Summary
Pooled analyses of data on COPD treatment show increased risk of stroke in two patients per 1,000, agency says.
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Use of Pfizer/Boehringer Ingelheim's chronic obstructive pulmonary medication Spiriva (tiotropium bromide monohydrate) may be linked to stroke, FDA says in a March 18 MedWatch alert. According to the agency, manufacturer BI conducted a pooled analysis of safety data from 29 studies of about 13,500 patients, and findings indicate that use of Spiriva is linked to an excess risk of any type of stroke in two patients for every 1,000. The company submitted the data from 25 studies of the Spiriva HandiHaler , and four trials of the formulation marketed in Europe, Spiriva Respimat . The analyses showed an excess risk of stroke of eight patients for every 1,000 taking Spiriva for one year, versus six patients for every 1,000 taking placebo. "It is important to interpret these preliminary results with caution," the agency says in an accompanying "Early Communication about an Ongoing Safety Review," noting it "has not yet confirmed these analyses." "FDA has requested additional information and is currently reviewing post-marketing adverse events reports with Spiriva." The agency points out it will have data from BI's four-year long-term Spiriva trial, UPLIFT, in June, and that data likely will inform any ongoing review of potential safety issues. FDA approved Spiriva in 2004 for the long-term treatment of bronchospasm associated with COPD (1 (Also see "Pfizer/Boehringer Spiriva For COPD Maintenance Therapy Approved By FDA" - Pink Sheet, 2 Feb, 2004.)). -Brooke McManus ([email protected]) |