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WASHINGTON, April 7 (Xinhuanet) -- Pfizer Inc. on Thursday agreed to halt
sales and marketing of its arthritis painkiller Bextra at the request of US Food
and Drug Administration (FDA).
Media reports said the company also took a similar move in Europe at the
European regulators. Canadian health authorities also required the Pfizer to
withdraw the drug.
The FDA also requested the Pfizer to use the black box -- the strongest it
can order -- warning label for its painkiller Celebrex, which has been in
studies linked with increased risk of heart attack and stroke.
In addition, the agency ordered dozens of other prescription or
nonprescription NSAIDs, or nonsteroidal anti-inflammatory drugs, including
ibuprofen and naproxen, which all are pain relievers, tocarry new tougher
warnings about risks of heart problems and gastrointestinal bleeding.
Aspirin is exempted from the FDA order for new warnings.
In explaining its decision on Bextra, the FDA said that besidescardiac
concern, Bextra appears to cause more cases of rare but serious and sometimes
fatal skin conditions.
"The overall risk-versus-benefit profile for the drug is unfavorable," it
said in a statement.
Last December, the FDA recommended limited prescription of Celebrex and
Bextra, which, like Merck & Co's Vioxx, are a part ofa subset of NSAIDs
known as COX-2 inhibitors. COX-2 inhibitors aredesigned to reduce the risk of
gastrointestinal bleeding associated with older painkillers like aspirin.
Merck voluntarily pulled its Vioxx out of the market last September after a
study linked it with increased risk of heart attack and stroke. Although an
advisory panel to the FDA in February approved the safety of Vioxx and its
return to market, the FDA said Thursday in a statement that it would "carefully
review any proposal from Merck for resumption of marketing of Vioxx."
The Pfizer said it "respectfully disagrees with FDA's position regarding
the overall risk/benefit profile of Bextra." The drug maker said it would
"explore options with the agency under which the company might be permitted to
resume making Bextra available to physicians and patients."
The sales of Pfizer's Bextra and Celebrex totaled 1.3 billion and 3.3
billion US dollars respectively in 2004. Enditem |