US FDA Warns Pfizer Over Painkiller Advertising

January 17, 2005

WASHINGTON (Reuters) Jan 13 - The U.S. Food and Drug Administration has

warned Pfizer Inc. that television and print advertisements for its

painkillers Celebrex and Bextra misled consumers, according to a letter made

public on Wednesday.

Five ads did not disclose side effects and other risk information and made

" unsubstantiated effectiveness claims, " the FDA said in the letter dated

Jan. 10 that was posted on its Web site,

Shares of Pfizer, after closing down 12 cents at $26.03 in regular trading

on the New York Stock Exchange, slipped to $25.90 in after-hours trading.

Company spokeswoman nn Caprino said the Celebrex advertisements cited

by the FDA were no longer running.

She had no comment on the other materials, including a Bextra patient

brochure and a promotional television infomercial. " There's very little

(direct-to-consumer advertising) on Bextra, anyway, " she said.

Caprino said the company would discuss " appropriate " next steps with the

FDA. Pfizer must respond to the agency by Jan. 26, the letter said.

The National Institutes of Health (NIH) suspended on Dec. 17 a cancer trial

using Celebrex after researchers found an increased risk of heart attack. An

NIH study on Alzheimer's disease using Celebrex, which was also canceled,

found no signs of heart attack risk.

The FDA has said it asked the drug company in December to suspend Celebrex

ads while agency officials reviewed the data, and the company agreed. Pfizer

also has placed a note on Bextra warning of an increased heart risk in

patients who had recent heart bypass surgery.

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