Based on a recent review, the FDA announced Jan. 15 that Pfizer/Boehringer Ingelheim Pharmaceuticals’ Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), does not support an increased risk of stroke, heart attack or death in patients using the medicine.
Spiriva HandiHaler consists of capsules and an inhalation device approved for once daily use in COPD, which is a serious, chronic lung disease that restricts air flow in the lungs resulting in shortness of breath and manifests itself in emphysema and chronic bronchitis.
In March 2008, the FDA’s early communication described data submitted by the manufacturer of Spiriva HandiHaler suggesting a small increased risk of stroke in patients treated with tiotropium, the agent’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.
Last week’s update to those communications is based on the FDA's review of the UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) study, comparing Spiriva HandiHaler with a placebo in 5,992 COPD patients. In November 2009, the FDA 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.