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Celebrex causes Pfizer pain

New York - US drug giant Pfizer will immediately and indefinitely stop advertising its painkiller Celebrex to consumers in the wake of research linking high doses to increased heart attack risk, The New York Times reported on Monday.

Some magazine advertisements may appear for a few more weeks owing to the long lead time in magazine advertising, Pfizer spokesperson Mariann Caprino told the Times.

"We discussed it with the FDA and we all concurred that it was the appropriate step," Caprino said.

Pfizer will continue marketing Celebrex, its bestselling arthritis pain reliever, to doctors, she said.

Pfizer said on Friday that a trial had found a sharp rise in heart attacks for patients using Celebrex but that it would not immediately withdraw the treatment.

The company spent $71m advertising Celebrex to American consumers in the first nine months of 2004, according to the Times.

Pfizer also deploys thousands of sales representatives to doctors' offices.

Celebrex is approved in the United States for the treatment of arthritis and pain at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis.

A study into the use of Celebrex to prevent benign tumours, or adenomas, showed patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5-fold increased risk of major cardiovascular problem compared to patients on a placebo, according to the National Cancer Institute.

The US Food and Drug Administration (FDA) is considering regulatory action and in the meantime advising doctors to lower the dose or consider alternative medications for their patients.

Celebrex is used by 26 million people, according to Pfizer, and is the latest COX-2 inhibitor drug to face controversy.

Vioxx, made by the rival Merck and Co, was withdrawn in September because of increased risk of heart attacks.

Pfizer chairperson Hank McKinnell repeated on Sunday that his company would leave Celebrex on the market for now, saying the study was just one among many.

He said Pfizer had conducted more than 50 clinical studies and five large reviews of Celebrex, involving more than 40 000 subjects. Some of them showed the heart risk with Celebrex "less than any other treatment option".

But David Graham, associate director of the FDA's Office of Drug Safety, had sharp words about the drug's risk and his own agency.

"The FDA wasn't concerned about Vioxx, and would not have removed it from the market if Merck hadn't, yet 100 000 patients had heart attacks because of Vioxx," Graham said on the same ABC program.

"The fact that the FDA says now that it's concerned about Celebrex to me is a serious signal. I would be very concerned," he said.

Graham blasted the FDA for not requiring larger safety studies before approving new drugs that carry theoretical risks, like the COX-2 class.

The agency instead allows the drug to continue to be tested in the general public, he charged.

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