FDA MedWatch

Tiotropium (Spiriva): updated information on risk of stroke and reports of cardiovascular adverse outcomes

Tiotropium (marketed as Spiriva HandiHaler)

Audience: Pulmonary care health professionals and patients

10/07/2008- FDA informed healthcare professionals that FDA has reviewed preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease. The preliminary results reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide compared to placebo.

Two recent publications reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes.

FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.

Read the complete MedWatch 2008 Safety summary, including a link both today's update and the original March 18th Early Communication, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tiotropium