FDA warns Pfizer over painkiller ads

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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, http://www.fda.gov/cder/warn/2005/12560-letter.pdf.

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 Mariann 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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