- WASHINGTON (Reuters) - U.S.
health officials urged doctors on Friday to consider prescribing alternatives
to Pfizer Inc.'s arthritis drug Celebrex while regulators weigh new data
on heart risks.
-
- "We do have great concerns about this product and
this class of products," Acting Food and Drug Administration Commissioner
Lester Crawford told reporters.
-
- Celebrex is part of the same family of drugs as Merck
& Co Inc.'s Vioxx, which the company pulled from the market Sept. 30
because it raised heart attack and stroke risk.
-
- The FDA is "keeping all options open" on Celebrex,
including adding a strong warning about safety risks or asking Pfizer to
limit consumer-directed advertising for the widely used painkiller, Crawford
said.
-
- The agency could ask Pfizer to pull Celebrex from the
market. Pfizer said Friday it had no plans to recall the drug.
-
- Crawford said the FDA would have more announcements about
Celebrex in the next few days.
-
- New concerns arose Friday after the National Institutes
of Health halted a trial testing Celebrex for cancer prevention, because
the drug more than doubled heart-attack risk compared with placebo. Patients
in the trial took Celebrex for 33 months on average, the FDA said.
-
- The NIH said it was reviewing all government grants for
studying Celebrex and other COX-2 inhibitors.
-
- If doctors do consider Celebrex appropriate for certain
patients, they should prescribe the lowest possible dose, FDA officials
said.
-
- Celebrex and other COX-2 inhibitors were designed to
relieve pain with a lower risk of life-threatening stomach bleeding than
older, over-the-counter drugs. Celebrex has been shown to cut the risk
of stomach ulcers but has not been proven to reduce the chances of serious
gastrointestinal bleeding, said Dr. John Jenkins, head of the FDA's Office
of New Drugs.
-
- The FDA has been under fire in recent months as being
slow to respond to serious drug side effects, and the Celebrex news prompted
more criticism.
-
- "Right now, we have a situation where the public
is left wondering when the next shoe might drop when it comes to drug safety,"
said Senate Finance Committee Chairman Charles Grassley, an Iowa Republican.
-
- Consumer group Public Citizen said the FDA should remove
Celebrex and Pfizer's other COX-2 inhibitor, Bextra, from the market immediately.
-
- The House of Representatives Energy and Commerce Committee
sent a letter to Pfizer asking for documents related to Celebrex and Bextra.
The letter said the committee was concerned about recent Pfizer statements
regarding the safety of Celebrex.
-
- Jenkins said the government had acted properly in its
oversight of Celebrex. Pre-approval reviews are not designed to catch all
side effects, making post-approval monitoring important, he said. No earlier
studies had suggested a significant heart risk with Celebrex, Jenkins said.
-
- "I don't see this as a failure of the system. This
is how drug development, drug approval and post-marketing monitoring is
done, not only in the United States but in all other countries who have
a regulatory system," Jenkins said.
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