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FDA Asked Pfizer To Halt Celebrex Ads

No Indication How Long Suspension Will Last

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DETROIT ( -- An official from the Food and Drug Administration this morning said the agency asked Pfizer on the night of Dec. 17 to suspend consumer advertising for Celebrex while it reviews
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data from a new study that found the drug more than doubled the risk of heart attack in some patients.

The official said there was no indication of how long the suspension would be.

Pfizer announced Dec. 17 that clinical trials showed high doses of Celebrex were associated with an increased heart attack risk. The pharmaceutical maker said the drug has not been shown to be dangerous to arthritis patients -- its original intent -- when taken at normal doses. The heart attack risk in the study disclosed Friday occurred when patients took the drug at two to four times the usual dose for several months.

Will stay on the market
Pfizer, which did not return calls this morning, has said it will suspend direct-to-consumer advertising and alter is marketing to doctors, but will not take the drug off the market.

The FDA made a public statement Dec. 17 that made no mention of the request to suspend advertising. The FDA said it had seen only the preliminary results of the studies and would "obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action."

$82 million in ad spending
Publicis Groupe's Kaplan Thaler Group of New York handles consumer advertising for Celebrex. Pfizer spent $86 million on the product last year, according to TNS Media Intelligence/CMR, and $48 million through the first seven months of this year. That projects out to about $82 million in media spending for 2004.

Kaplan Thaler did not return calls.

Celebrex is in a class of drugs called COX-2 inhibitors, a group that has come under increased scrutiny. Pfizer also produces a related drug called Bextra; combined, they were expected to bring in almost $4 billion in sales this year.

In September, Pfizer rival Merck pulled its COX-2 drug, Vioxx, from the market. Merck took that action after a study revealed heart attack and stroke risk was doubled for long-term Vioxx users.

Sales spiked after Vioxx recall
Ironically, IMS Health Corp. reported this morning that in October, the first full month of data after the Vioxx withdrawal, sales of Celebrex topped $260 million, or 63.5% of the market for COX-2 inhibitors. In September, Celebrex had accounted for 48.7% of the market.

In pre-market trading this morning, shares of Pfizer lost 0.5% to $25.88 following the news that the company was suspending its advertising for Celebrex.

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Lisa Sanders contributed to this report.

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