FDA, Boehringer Ingelheim release warning over Spiriva

WASHINGTON The Food and Drug Administration and Boehringer Ingelheim have sent out a notice that Boehringer’s chronic obstructive pulmonary disease treatment drug Spiriva may possibly increase the risk of stroke in patients using the drug.

Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies. Based on data from these studies, the preliminary estimates of the risk of stroke are eight per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 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 per 1,000 using the drug over a one-year period.