FDA panel: Approve Celebrex for kids despite risk

NEW YORK (CNNMoney.com) -- Food and Drug Administration advisers voted in favor of approving the Pfizer painkiller Celebrex as an effective treatment of rheumatoid arthritis for children, even though it is not safe.

The advisory panel unanimously determined that Celebrex is effective in children with arthritis but voted 8-7 that it is not safe for children, with one abstention. In addition, the panel decided 15-1 that the benefit of Celebrex outweighed the risk and recommended its approval for children.

Votes for advisory panels are not final. They are suggestions that are considered by the FDA when reviewing drugs for possible approval.

The FDA follows the advice of its expert panels most of the time, so the advisory vote is a strong indication of the drug's outcome. The final decision could be months away.

Celebrex is currently on the market as an anti-inflammatory painkiller for arthritis, and it has been approved for many other indications as well. The drug is a blockbuster, with sales totaling $1.5 billion in the first nine months of 2006, and Pfizer (up $0.02 to $27.07, Charts) is on track to reach its sales goal of $2 billion for the year.

But Celebrex sales from this year are significantly less than its $3.3 billion sales total from 2004. That's because Celebrex is tainted by its classification as a Cox-2 inhibitor and an NSAID (nonsteroidal anti-inflammatory, like naproxen and ibuprofen), making it a member of the same drug class as Merck's (up $0.89 to $44.56, Charts) Vioxx and Pfizer's Bextra. These are former blockbusters that were taken off the market in 2004 and 2005 because of links to increased heart attack risk.

Celebrex was not taken off the market, though in May 2005 the FDA required a strong "black box" warning label that said the drug "may increase the chance of a heart attack or stroke can lead to death." The label also contains warnings of stomach bleeding.

Going forward, Steve Romano, vice president for Pfizer's worldwide medical organization, announced that a 20,000-patient study is being conducted that compares the cardiovascular risk of Celebrex to the NSAIDs naproxen and ibuprofen.

"That will help clarify whether there's a differential risk between these drugs," said Romano, noting that Pfizer is funding the study, which is being conducted by the Cleveland Clinic.

Merck's Cox-2 inhibitor Arcoxia is on the market in 62 countries, and the company is seeking approval in the United States.

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