|FDA warning links Spiriva with stroke risk. Source: ww.yle.fi|
The FDA and Boehringer Ingelheim have notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take the respiratory medicine Spiriva.
The product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease.
Boehringer Ingelheim reported to the FDA that it has conducted a pooled analysis of the safety data from 29 placebo controlled clinical studies. Based on data from the studies, the preliminary estimated the stroke risk is eight per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with placebo.
The results mean 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 is working with Boehringer Ingelheim to further evaluate the potential association between Spiriva and stroke.
The FDA has also not confirmed the analyses, called UPLIFT. The agency said that while pooled analyses can provide early information about potential safety issues, the analyses have inherent limitations and uncertainty that require further investigation using other data sources.