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Celebrex Gets Black Box Label

August 2, 2005
Celebrex, the only COX-2 painkiller still on the market in the U.S., will carry the Food and Drug Administration’s toughest warning. The FDA has announced the drug will carry a so-called “black box” on its label, warning consumers of increased cardiovascular risks.

Celebrex • Celebrex May Disrupt Heart Rhythm • Celebrex Gets Black Box Label • FDA Blasts Ads For Celebrex, Bextra • Can Pfizer Prevent Celebrex Ban? • Pfizer Finds Health Risk With Celebrex • Study Finds Celebrex Safer Than Vioxx • Celebrex Implicated in 14 Canadian Deaths --- Other NSAIDs • Merck Withdraws Vioxx • Pfizer Warns of Bextra Risks • Aleve Ingredient Seen as Health Risk •: Dangers of Cox-2 Drugs • Life Without Vioxx

Similar warnings have been mandated for ibuprofen and naproxen.

Celebrex has been under close scrutiny since late last year, when Merck withdrew another COX-2 drug, Vioxx from the market. The FDA then asked Pfizer to take similar action with its COX-2 drug, Bextra.

"We have worked closely with the FDA to ensure that Celebrex's label provides physicians and patients with the information they need to make the most appropriate and most informed treatment decisions," said Dr. Joseph Feczko, Pfizer's chief medical officer.

The new warning on Celebrex's label will recommend the drug be prescribed at the lowest dose and shortest time possible. Doctors are also being cautioned that Celebrex should not be used following heart bypass surgery.

While toughening the warning label, the FDA has approved the use of Celebrex for treatment of ankylosing spondylitis, a rare form of arthritis in the spine. It continues as an approved pain reliever for osteoarthritis and rheumatoid arthritis.

Pfizer says the recommended dose for Celebrex is 200 mg daily for osteoarthritis and 200 mg to 400 mg daily for adult rheumatoid arthritis. For the management of the signs and symptoms of ankylosing spondylitis, the recommended dose of Celebrex is 200 mg daily in single or divided twice per day doses.

In a way, the “black box” warning marks a victory for Pfizer’s strategy of keeping Celebrex on the market. The pharmaceutical company came under strong pressure late last year to withdraw the drug, as Merck had done with Vioxx. A Toronto newspaper published documents in which Canadian health officials blamed Celebrex for 14 deaths in Canada.

But Merck took a major financial hit when it withdrew Vioxx and Pfizer seemed determined to avoid that fate. In December company executives strongly defended Celebrex, but pulled all radio and TV advertising for the drug.

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