Drug manufacturer Boehringer Ingelheim has told health regulators in the US that patients using its respiratory inhaler may face a greater risk of stroke.
The Food and Drug Administration (FDA) has confirmed that data submitted by the German pharmaceutical firm show there is a slightly higher rate of stroke for patients using its Spiriva Handihaler, compared with a placebo.
The FDA said that so far it has not analysed the figures, which were compiled from 29 patient studies.
According to the report submitted by Boehringer Ingelheim, two out of every 1,000 patients using Spiriva are at risk of having a stroke.
The group jointly markets the Spiriva inhaler with Pfizer, and the device is approved in the US to treat chronic obstructive lung disease, including chronic bronchitis and emphysema.
It is believed that Boehringer will submit more safety data to the FDA in June.
Until then, the agency is recommending that doctors and patients report any side-effects of inhaler use immediately.
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