FDA Checking on Spiriva and Stroke
FDA, Drug Maker Probing Possible Increased Risk of Stroke in Patients Who Use Spiriva HandiHaler
March 18, 2008 -- The FDA and the drug company Boehringer Ingelheim are investigating a possible increase in stroke risk among patients who use the Spiriva HandiHaler, an inhaler used to treat chronic obstructive pulmonary disorder (COPD).
That possibility, noted in a preliminary analysis, isn't certain. It's not yet clear if Spiriva HandiHaler caused any strokes.
More information is needed to put the data in perspective; the FDA expects to get more data in June when a four-year Spiriva study wraps up.
Meanwhile, "patients should not stop taking Spiriva HandiHaler before talking to their doctor," states an FDA news release.
Boehringer Ingelheim discovered and makes Spiriva HandiHaler and co-markets it with Pfizer.
A Boehringer Ingelheim news release notes that those two drug companies "voluntarily and proactively" informed the FDA of their preliminary analyses of stroke risk in Spiriva patients.
Those analyses, which haven't been confirmed by the FDA, are based on data pooled from 29 clinical trials that compared Spiriva HandiHaler (or its European version, Spiriva Respimat) to a placebo.
Together, the trials included about 13,500 COPD patients, according to the FDA.
"Based on data from these studies, preliminary estimates of the risk of stroke are eight patients per 1,000 patients treated for one year with Spiriva, and six patients per 1,000 patients treated for one year with placebo," states the FDA. "This means that the estimated excess risk of any type of stroke due to Spiriva is two patients for each 1,000 patients using Spiriva over a one-year period."
The FDA urges caution in interpreting the preliminary findings.
"Pooled analyses can provide early information about potential safety issues. However, these analyses have inherent limitations and uncertainty that require further investigation using other data sources," states the FDA. Boehringer Ingelheim and Pfizer agree with that, according to Boehringer Ingelheim's news release.
Boehringer Ingelheim advises patients to ask their doctors if they have questions about Spiriva treatment; doctors may call Boehringer Ingelheim at 800-542-6257 with Spiriva questions.
The FDA approved Spiriva in 2004. More than eight million patients worldwide have been treated with Spiriva, according to Boehringer Ingelheim.