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Why Did the FDA Issue a Warning Statement About the COPD Medication Spiriva?

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Updated December 22, 2010

Spiriva and COPD

FDA Warning About Spiriva

Photo © A.D.A.M.
Question: Why Did the FDA Issue a Warning Statement About the COPD Medication Spiriva?
At one time, the FDA issued a warning that Spiriva may have some pretty serious health risks. However, the latest update from the FDA states that this information is unsupported. To follow is the initial warning and the updated information:
Answer:

Have you ever used the lung medication, Spiriva for your COPD symptoms? If you have, it may behoove you to know that on March 18, 2008, the Food and Drug Administration (FDA) issued a warning statement that Spiriva, marketed by Pfizer, Inc. and Boehringer Ingleham Pharmaceuticals Inc. may increase your risk for stroke.

The FDA has stated that their information is not yet fully conclusive, but they wanted to issue the statement in an effort to advise physicians and patients about potential dangers associated with the drug.

Allegations that the FDA has been too slow to notify the public about safety issues related to drugs and devices appear to have influenced the agency's decision to make this recent notification regarding Spiriva, even though the actual likelihood or extent of an increased risk of stroke with this drug has not yet been finally determined.

Because the FDA has not yet confirmed the preliminary results, they reported that "it is important to interpret these preliminary results with caution. FDA has not yet confirmed this analysis." Additionally, they have recommended that patients NOT stop taking Spiriva, but to report any problems to the agency.

As a patient it is important to be aware of risk factors associated with the medications you are taking. Be sure to talk with your doctor about concerns you may have about Spiriva, or any other medication, in an effort to make informed decisions about your health care.

UPDATE: On January 14, 2010, the FDA issued a press release acknowledging that Spiriva does NOT increase risk of stroke or other cardiovascular events, as had been reported previously.Visit my blog for more information..

Sources:

COPD News http://www.topix.com/health/copd 26 March 2008.

Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006. Available from: http://www.goldcopd.org.

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