The Food and Drug Administration said this week that it was conducting a safety review of Spiriva, a respiratory drug administered by way of an inhaler, after studies linked it to a slightly higher risk of stroke.
Spiriva is used to treat chronic obstructive pulmonary disease (COPD), a condition commonly caused by smoking. COPD is one of the leading causes of death in the United States.
Study Results
Boehringer Ingelheim, the maker of Spiriva, submitted the results of more than two dozen studies on the drug to the FDA. Most of the studies involved the Spiriva HandiHaler.
Preliminary findings showed that Spiriva increased the risk of stroke for an additional two patients per 1,000 per year when compared with placebo.
More Information Needed
“Additional information is needed to further evaluate this preliminary information about stroke in patients who take Spiriva HandiHaler,” the FDA said in a statement.
Results of a more extensive four-year study on the drug are expected to be released in June.