The FDA has reported that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.
In the US, COPD includes two main conditions, emphysema and chronic bronchitis. Spiriva HandiHaler consists of capsules and an inhalation device approved for once daily use in COPD.
A March 2008 FDA Early Communication had described data submitted by the manufacturer of Spiriva HandiHaler as suggesting a small increased risk of stroke in patients treated with tiotropium, the medicine’s active ingredient. In October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium, said the FDA.
The update is based on a review of the ‘Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT)’ study that compared Spiriva HandiHaler with a placebo in 5,992 COPD patients. In November 2009, the FDA’s Pulmonary Allergy Drugs Advisory Committee also reviewed the data and voted that findings from the UPLIFT study resolved the potential safety concerns for Spiriva Handihaler.