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Pfizer seeks FDA approval to prescribe Celebrex to toddlers as young as 2

Friday, December 01, 2006 by: Jessica Fraser
Tags: Celebrex, Pfizer, COX-2 inhibitors

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(NewsTarget) Drug giant Pfizer Inc. is set to meet this Wednesday with a panel of advisors from the Food and Drug Administration to review the company's request to expand the use of its painkiller Celebrex -- which has been linked to serious heart risks -- in children as young as 2.

Celebrex -- the first FDA-approved Cox-2 inhibitor on the market -- was shown in recent tests to double or even triple the risk of heart attack, stroke and death. The anti-inflammatory drug is the last Cox-2 inhibitor left on the market after Merck & Co. pulled Vioxx in late 2004, following news that it doubled the risk of heart attack and stroke in patients.

A 2004 study funded by the National Cancer Institute to test the effects of Celebrex in preventing colon cancer was halted early after patients experienced high rates of heart attack, heart death and stroke.

Patients taking a daily 400 mg dose of the drug had 2.5 times as many heart attacks, strokes and deaths as control patients, while those taking 800 mg of the drug per day had 3.4 times the cardiovascular events as the control group.

Though experts are calling for Celebrex to be pulled from the market, Wednesday's meeting between Pfizer and the FDA will determine if the drug's benefits outweigh its risks in children as young as 2 who have arthritis.

Consumer health advocate Mike Adams, author of "Grocery Warning," said it was "outrageous" that the FDA would consider approving idea of treating toddlers with dangerous arthritis drugs.

"Drugging our babies with toxic painkillers that greatly increase the risk of heart attacks and strokes is not the way to raise a generation of healthy children," Adams said. "If there was anything resembling sanity remaining at the FDA, they would look at this idea in astonishment and reject it outright."

FDA adviser Arthur Levin, who was invited to attend Wednesday's meeting, said previously that all sales of Celebrex should be halted.

Pfizer is also under fire from critics who say the company heavily promoted the painkiller through direct-to-consumer advertising before all its risks were known.


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