Pfizer
to add warning to Celebrex
August
1, 2005 (Reuters Health)
NEW
YORK (Reuters) - Pfizer Inc. on Monday said the label of
its Celebrex arthritis drug has been changed to add a prominent
warning of possible cardiovascular risks, such as increased
risk of heart attacks, in line with new warnings of other
arthritis and pain drugs.
New
York-based Pfizer said the package insert label of the drug
-- one of the company's biggest products, sales of which
have recently declined sharply due to safety concerns --
recommends it be prescribed "at the lowest effective
dose for the shortest duration."
The
company also said U.S. regulators had approved a new use
for the drug, treating ankylosing spondylitis, a form of
arthritis that affects the spine.
Second-quarter
revenue from Celebrex plunged 45 percent to $401 million,
one reason the world's largest drug maker expects a modest
decline in company revenue this year.
A federal
advisory panel of doctors in February said Celebrex "significantly"
raised the risk of heart problems and strokes. But the advisors
to the U.S. Food and Drug Administration recommended it
remain on the market because of its benefits to arthritis
patients.
Pfizer
last month said its sales forces were holding back on fully
promoting Celebrex again until it knew the warning language
the FDA will require on the drug's label.
Safety
concerns about Celebrex and other painkillers intensified
after Merck & Co. Inc. withdrew its Vioxx arthritis
treatment in September when it was shown to double the risk
of heart attack and stroke after long-term use.
Celebrex
and Vioxx are both newer arthritis treatments designed to
block pain with far less risk of ulcers and other gastrointestinal
problems than conventional non- steroidal anti-inflammatory
drugs (NSAIDs), such as aspirin and naproxen.
But
one of the largest and most important trials conducted on
Celebrex failed to show the drug reduced such gastrointestinal
risk by a statistically significant degree, although favorable
trends were seen.
Even
so, Pfizer has widely advertised Celebrex and turned the
expensive medicine into a blockbuster product.
Pfizer
shares were up 16 cents to $26.66 in midday trading on the
New York Stock Exchange, in line with slight gains for the
drug sector.
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