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Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Cautions on COPD Inhaler and Stroke Risk
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The U.S. Food and Drug Administration cautioned Tuesday that a respiratory inhaler used for chronic obstructive pulmonary disease may heighten the risk for stroke.
The agency said that German drug maker Boehringer Ingelheim, which manufactures Spiriva HandiHaler, reported that ongoing safety monitoring identified a possible increased risk of stroke in patients who take the medicine.
The inhaler contains tiotropium bromide and is used to treat bronchospasm associated with COPD, the FDA said in a prepared statement, adding that additional information is needed to further evaluate this preliminary information.
Boehringer Ingelheim reported that it has conducted an analysis of the safety data from 29 placebo-controlled clinical studies involving 13,500 patients with COPD, the FDA said. In 25 of the clinical studies, patients were treated with Spiriva HandiHaler, which is a once-daily, long-term maintenance medicine. In the other four, patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat.
Based on data from these studies, the FDA statement said, the preliminary estimates of the risk of stroke were eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with a placebo. That translates to an estimated excess risk of any type of stroke due to Spiriva to two patients for each 1,000 patients using Spiriva over a one-year period.
The FDA said it was working with the drug maker to evaluate the potential link, and it cautioned patients using Spiriva to not stop using the medication without talking to their doctors.
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