WASHINGTON The lung drug Spiriva, marketed by
Pfizer Inc (PFE.N) and Boehringer Ingelheim Pharmaceutical Inc,
may increase the risk of stroke, the U.S. Food and Drug
Administration said on Tuesday.
The FDA said the risk assessment was not yet conclusive,
but it was issuing a statement as part of an effort to tell
doctors and patients about potential problems as soon as
possible. The agency said it was working with Boehringer to
evaluate the possible risk.
Spiriva HandiHaler is used to treat chronic obstructive
pulmonary disease, or COPD, and is co-promoted worldwide by
Pfizer and Boehringer Ingelheim, a privately held German
A preliminary company analysis of about 13,500 patients
from 29 clinical studies found that risk of stroke was 8 in
1,000 patients taking the once-daily inhaled drug, compared
with 6 in 1,000 who took a placebo, the FDA said. The agency
has not confirmed the results, it added.
Four of the studies involved a version of Spiriva approved
in Europe called Spiriva Respimat.
In a statement, Boehringer said the companies were
"continuing to evaluate information from a variety of sources."
It did not say when its final analysis of the data would be
completed. Representatives for Pfizer referred calls to
The FDA has come under fire in recent years for its failure
to quickly notify the public about safety problems with drugs
Agency officials have defended their actions, but also
agreed to make public any potential problems sooner before
fully reviewing the concerns. Critics have said this new
approach could scare patients and doctors away from needed
"It is important to interpret these preliminary results
with caution. FDA has not confirmed these analyzes," the FDA
said in a statement posted on its Web site here
The FDA said patients should not stop taking Spiriva, but
should continue to report problems to the agency.
Known chemically as tiotropium, Spiriva has replaced
Boehringer's older drugs -- Atrovent and Combivent -- that are
used several times a day. The company declined to release
Spiriva's sales figures.
Pfizer shares closed up 43 cents, or 2 percent, to $21 on
the New York Stock Exchange.
(Editing by Andre Grenon)