SILVER SPRING, Md., Jan. 14 /PRNewswire-USNewswire/ -- 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.
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.
Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm197429.htm
CONTACT: Erica Jefferson of FDA, +1-301-796-4988,
erica.jefferson@fda.hhs.gov
Web site: http://www.fda.gov//
