You are here

FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

January 14, 2010 -- The U.S. Food and Drug Administration today announced 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.

COPD is a serious and chronic lung disease that restricts air flow in the lungs resulting in shortness of breath. In the United States, 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.

Today’s update of those communications is based on an FDA 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 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.

Source: Food and Drug Administration

Recent Headlines

New drug addresses bacterial resistance to standard therapy
Hovering flights lower packages by cable and winch
Ziextenzo helps lower the incidence of febrile neutropenia
The answer may offer a potential treatment for the disease
Drug resistance in HIV patients has nearly tripled since 2001
Drug resistance in HIV patients has nearly tripled since 2001
The number of those with an annual drug spend of $250K or more has increased by 60%
Grading manufacturers would give high-quality, reliable makers a boost, says federal panel
Sharpless is heading back to NCI