What stroke risk is associated with Spiriva?
“Based on data from these studies, preliminary estimates of the risk of stroke are eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with placebo,” states the FDA. “This means that the estimated excess risk of any type of stroke due to Spiriva is two patients for each 1,000 patients using Spiriva over a one-year period.” The FDA urges caution in interpreting the preliminary findings. “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,” states the FDA. Boehringer Ingelheim and Pfizer agree with that, according to Boehringer Ingelheim’s news release.
