Initial concerns over Spiriva HandiHaler may be unfounded, agency says
THURSDAY, Jan. 14 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday said it found no good evidence that the Spiriva HandiHaler boosts heart risks in patients who use it to help control chronic obstructive pulmonary disease (COPD).
The announcement comes after data released in early 2008 by the drug's maker, "suggesting a small increased risk of stroke in patients treated with tiotropium [Spiriva], the medicine's active ingredient," the FDA noted in a statement.
In October of 2008, the agency released an "Updated Early Communication" that pointed to two other studies suggesting a boost in risk of stroke, heart attack and death among users of the Spiriva HandiHaler.
But a study published in the January 2010 issue of Chest found the opposite: that tiotropium might lower users' risk of heart problems and death.
Spiriva is one of the most commonly prescribed daily treatments for COPD, a progressive respiratory illness combining bronchitis and emphysema that is often linked to smoking. COPD is the fourth-largest killer in the United States.
The Spiriva HandiHaler consists of a capsule used with an inhaler, to be taken once daily. Spiriva is from the class of drugs known as anticholinergics, which also includes the widely used ipratropium bromide (Atrovent).
Thursday's FDA announcement should come as a relief to COPD patients who rely on the Spiriva HandiHaler. In its statement, the FDA said its review of the data does "not support an increased risk of stroke, heart attack, or death in patients using the medicine."
"Today's update 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," the agency said. "In November 2009, the FDA Pulmonary-Allergy Dr
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