March 18, 2008WASHINGTON (AP) -- Drug maker Boehringer Ingelheim has told regulators that patients using its respiratory inhaler may face a greater risk of stroke.
The Food and Drug Administration said Tuesday that data submitted by the German drug maker show a slightly higher rate of stroke for patients using its Spiriva Handihaler, compared with a placebo. FDA said it has not yet analyzed the figures, which were compiled from 29 patient studies.
According to the company's analysis, two out of every 1,000 patients using Spiriva are at risk for stroke.
Boehringer jointly markets the Spiriva inhaler with Pfizer Inc. The device is approved to treat chronic obstructive lung disease, including chronic bronchitis and emphysema.
Boehringer is expected to report more safety data in June.
Until then, FDA recommends that doctors and patients report any side effects of inhaler use.
Shares of New York-based Pfizer Inc. rose 22 cents Tuesday to $20.79 in afternoon trading.
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