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FDA Gives Celebrex New Warning Label and New Indication

Aug 3, 2005 | In a bureaucratic mixed message, the FDA finalized a long-anticipated black box warning for the Celebrex (celecoxib) label on the same day that the agency approved the drug for ankylosing spondylitis, a new indication.

In April, an independent panel of advisers convened by the FDA recommended the black box warning for Celebrex and other NSAIDs, including ibuprofen and naproxen. The panel was convened after published reports that Cox-2 inhibitors such as Celebrex increases the risk of cardiovascular events.

Last September, Merck withdrew its popular Cox-2 Vioxx (rofecoxib) from the market after investigators in a cancer-chemoprevention trial reported that long term use of the drug increased the risk of heart attacks and strokes, although it did not increase cardiovascular mortality. Earlier this year, Pfizer, which makes Celebrex, withdrew its other Cox-2, Bextra (valdecoxib), when similar reports surfaced about it. Celebrex is the only Cox-2 remaining on the market.

The Cox-2 cardiovascular risk link prompted researchers to review studies of other NSAIDs, which turned up apparent increased cardiovascular events associated with those drugs as well. The bottom line, the FDA advisory group concluded, was that all the painkillers with the exception of aspirin should receive new labels to reflect the increased risk.

Celebrex's label will recommend that the drug be prescribed at the lowest dose and shortest time possible. The label will also carry a warning that Celebrex should not be used to treat pain associated with heart bypass surgery.

In announcing agreement with the FDA over the new label, Pfizer said the agency approved Celebrex for ankylosing spondylitis, or arthritis of the spine, which affects about 400,000 Americans. With the new indication, Celebrex is now approved for treatment of osteoarthritis, rheumatoid arthritis and as a treatment for familial adenomatous polyposis.

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