FDA evaluates Spiriva stroke risk
The FDA has evaluated preliminary safety data that show no increased risk of stroke with Spiriva HandiHaler (tiotropium bromide inhalation powder, from Boehringer Ingelheim) compared to placebo. The data originates from UPLIFT, a clinical trial designed to study the long-term safety of Spiriva in approximately 6,000 patients with chronic obstructive pulmonary disease (COPD). After receiving the complete UPLIFT report, expected in November 2008, the FDA will release its final conclusions and recommendations regarding Spiriva and its potential stroke risk.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm095076.htm.