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admin March 19th, 2008

The FDA have announced in an early communication that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take tiotropium.

Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). In 25 of the clinical studies, patients were treated with Spiriva HandiHaler. In the other 4 clinical studies patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat. The 29 clinical studies included approximately 13,500 patients with COPD. Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.

It is important to interpret these preliminary results with caution. FDA has not confirmed these analyses. Pooled analyses can provide early information about potential safety issues. However, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

No causal relationship is as yet proven. The FDA are currently reviewing post-marketing data and further data from the UPLIFT study will be available in June of this year.

Bottom line: There is no proven link between stroke and tiotropium at present. However, healthcare professionals should be aware that any suspected adverse effects to tiotropium can be reported via the Yellow Card scheme.

• FDA
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