FDA calls Pfizer ads misleading

January 13, 2005|Associated Press

WASHINGTON -- Advertisements for painkillers Celebrex and Bextra were misleading and unsubstantiated, overstating the drugs' benefits and understating the risks, the government said yesterday.

The Food and Drug Administration asked for an immediate halt to all ads for Celebrex, which Pfizer Inc. did last month in advance of the agency's letter. A study in December found high doses of Celebrex were associated with an increased risk of heart attack.

The letter, sent Monday and released yesterday, details the misleading and unsubstantiated claims in ads for Celebrex and a related drug, Bextra, that appeared on television, in print, on TV infomercials, and in direct-mail brochures.

The government said the claims represent serious violations of federal law.

Pfizer spokeswoman Mariann Caprino told Reuters the company would discuss "appropriate" next steps with the FDA. Pfizer must respond to the agency by Jan. 26, the letter said

New York-based Pfizer spent more than $70 million advertising best-selling Celebrex to US consumers in the first nine months of last year.

It has run minimal consumer ads promoting Bextra.

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