Neurologist

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Drug Information Update: FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


 

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.

For more information please visit: Spiriva

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January 15, 2010 - Posted by | 1

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