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01/21/2010 - News

Spiriva Not Linked to Increased Risk of Stroke

By: June Chen, MD

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In March 2008, the U.S. Food And Drug Administration (FDA) issued Early Communications describing a potential increase in the risk of stroke, heart attack, or death from cardiovascular cause related to the use of tiotropium, marketed as Spiriva HandiHaler. Now, the FDA has completed its review and issued a Follow-Up stating that it does not believe the available scientific data support an association between the use of Spiriva HandiHaler and stroke or other serious cardiovascular adverse events.

Spiriva HandiHaler is a medication used for the treatment of chronic obstructive pulmonary disease. The FDA is basing its review on an analysis of the Understanding the Potential Long-Term Impacts of Function with Tiotropium (UPLIFT) trial. UPLIFT was a large, 4-year clinical trial comparing Spiriva HandiHaler to placebo in 5,992 people with chronic obstructive pulmonary disease. In the UPLIFT trial, there was no significant increase in the risk of stroke, heart attack, or cardiovascular death between Spiriva HandiHaler and placebo.

The FDA is advising healthcare professionals to continue to prescribe Spiriva HandiHaler as recommended on the drug label. Patients who are currently using Spiriva HandiHaler should talk to their healthcare professional if they have any questions or concerns about the use of Spiriva HandiHaler.

 

Source:

U.S. Food and Drug Administration website, accessed 20 January 2010.

 

Created on: 01/20/2010
Reviewed on: 01/21/2010

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