Monday, March 24, 2008
Article from the March 18 Wall Street Journal -- Boehringer Inhaler Might Pose Higher Stroke Risk, FDA Says, by Jennifer Corbett Dooren. Here's an excerpt:
The Food and Drug Administration said Tuesday it is opening a safety review of Boehringer Ingelheim GMBH's respiratory drug Spiriva after the company reported a possible higher risk of stroke to the agency.
In an "early communication" posted on the FDA's Web site, the agency said Boehringer Ingelheim submitted the results of 29 studies involving Spiriva, an inhaler that treats patients with chronic obstructive pulmonary disease, which showed a slightly higher rate of stroke among patients treated with Spiriva compared to those not receiving the drug. Most of the studies looked at Spiriva's HandiHaler, which is co-marketed with Pfizer Inc.
"Additional information is needed to further evaluate this preliminary information about stroke in patients who take Spiriva HandiHaler," the FDA said. The agency said it has requested additional information from the company and is reviewing post-marketing adverse events reported to FDA involving Spiriva.