updated 1/14/2010 4:42:44 PM ET 2010-01-14T21:42:44

Federal health regulators said Thursday that recent data do not show a connection between a popular inhaler and previously reported risks of stroke, heart attack and death.

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The Spiriva HandiHaler is made by German drugmaker Boehringer Ingelheim and co-marketed in the U.S. with Pfizer. The device uses tiny drug capsules and an inhalation tube to treat chronic obstructive pulmonary disease, which causes coughing, wheezing and shortness of breath.

The FDA began investigating Spiriva's safety last March after Boehringer reported slightly higher rates of stroke and heart attack for patients using its device, compared with a placebo.

The FDA now says a recent review of a company-sponsored, 6,000-patient study did not show evidence of increased risk. In November, an FDA panel of outside experts voted that the same study resolved safety concerns over Spiriva.

Since then, the FDA approved stronger labeling claims on the device about its ability to fight symptoms of lung disease.

Pfizer said in a statement that it welcomed the FDA's conclusion.

"This reaffirms the well-established safety profile of Spiriva Handihaler," the company said.

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