FDA launches safety review of Boeh Ing's Spiriva as pooled analysis shows stroke risk

The US Food and Drug Adminsitration has launched a safety review of Spiriva (tiotropium), after German drug major Boehringer Ingelheim submtted data on the chronic obstructive pulmonary disorder drug highlighting the possible risk of stroke.

The agent, which is co-developed with world pharmaceutical giant Pfizer, is used to treat bronchospasm associated with COPD. Additional information is needed to further evaluate this preliminary information about stroke in patients who take Spiriva HandiHaler, the agency noted.

Boehringer reported to the FDA that it has conducted an analysis of safety data from 29 placebo-controlled clinical studies. In 25 of these, patients were treated with Spiriva HandiHaler. In the other four clinical studies, patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat. These trials included approximately 13,500 patients with COPD.